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游离雌三醇测定试剂盒(时间分辨荧光免疫分析法)产品技术要求模板

医疗器械产品技术要求编号：游离雌三醇测定试剂盒（时间分辨荧光免疫分析法）1.产品型号/规格及划分说明1.1产品型号/规格96人份/盒（半自动）、96人份/盒（全自动）。

1.2结构组成试剂盒由uE3校准品（冻干粉）、uE3标记物（冻干粉）、uE3抗体、uE3实验缓冲液、浓缩洗液、增强液和uE3微孔反应板组成。

1.3 适用范围用于定量检测人体血清中的游离雌三醇含量。

2.性能指标2.1装量实验缓冲液、增强液、浓缩洗液的最大允许负偏差为 6.0％。

2.2外观试剂盒中校准品、标记物为冻干粉，呈白色或者淡黄色粉末或块状物，复溶后为澄清或浅黄色液体，不应含异物、混浊或摇不散的沉淀；其它液体组份试剂均为澄清透明；微孔反应板应封口良好，无破损。

2.3最低检测限试剂盒的最低检测限应不高于 0.6 nmol/L。

2.4特异性）交叉反应系数应不高于 2%；与孕酮（P）交叉反应系数应不高于与雌二醇（E22%。

2.5线性相关系数试剂（盒）的线性范围（0.6～49.2）nmol/L 内的线性应符合如下要求：a)线性相关系数 r≥0.990；b)检测浓度＜4 nmol/L 的uE3 时，线性的绝对偏差的绝对值应在 0.5 nmol/L 的范围内；检测浓度≥4 nmol/L 的uE3 时，线性相对偏差的绝对值≤15%。

2.6校准品的准确性用国家标准品制备的二级线性校准品（注册检验时使用）或经国家标准品标化的企业参考品对产品校准品（零值除外）的浓度进行测定，产品校准品 B、C 点的实测浓度与标示浓度绝对偏差的绝对值应在 0.5 nmol/L 的范围内，产品校准品 D～F 点的实测浓度与标示浓度相对偏差的绝对值≤20%。

2.7测量准确度用试剂盒对检测范围内低、中两个浓度人血清样本进行回收实验，其回收率应在（85%~115%）范围内。

2.8测量精密度2.8.1 校准品不精密度（均一性）试剂盒校准品（零值除外）B 点、C 点的不精密度（CV）应不超过 20.0%；D 点、E 点、F 点的不精密度（CV）应不超过 15.0%。

Healthy Blue SC会员手册说明书

December 2019BlueChoice HealthPlan is an independent licensee of the Blue Cross and Blue Shield Association. BlueChoice HealthPlan has contracted with Amerigroup Partnership Plan, LLC, an independent company, for services to support administration of Healthy Connections.To report fraud, call our confidential Fraud Hotline at 877-725-2702. You may also call the South Carolina Department of Health and Human ************************************************************.BSCPEC-1596-19 December 2019This is an update about information in the provider manual. For access to the latest manual, go online to .Quarterly pharmacy formulary change noticeWe reviewed and approved the formulary changes listed in the table below at the second quarter Pharmacy and Therapeutics Committee meeting.What does this mean to me?• Effective February 1, 2020, preferred and non-preferred formulary changes will apply. • Effective February 1, 2020, utilization management (UM) edits requirements will apply. • This notice applies to all Healthy Connections members.Effective for all patients on February 1, 2020Therapeutic class DrugRevised status Potential alternativesORALANTIHISTAMINESDIPHENHYDRAMINE 6.25MGSOLUTIONLORATADINE 5MG CHEWABLETABLETPREFERREDN/AORALANTIHISTAMINESED CHLORPED 2MG/ML LIQUID SILPHEN COUG 12.5/5ML SYRUP CLEMASTINE 2.68MG TABLET NON-PREFERRED CHLORPHENIRAMINE4MG TABLETSED CHLORPED JR SYRUPDIPHENHYDRAMINE12.5/5MLLIQUIDCLEMASTINE 1.34 MG OTCORAL NSAIDS(GENERIC)FENOPROFEN 200MG CAPSULE FENOPROFEN 400MG CAPSULE FENOPROFEN 600MG TABLET MEFENAM ACID 250MG CAPSULE NAPROXEN SOD 375MG CR TABLET NAPROXEN SOD 500MG CR TABLETPREFERRED N/A ORAL NSAIDS(BRAND) EC-NAPROSYN 375MG TABLET EC-NAPROSYN 500MG TABLET ADVIL CHILD 100/5ML SUSPENSION NON-PREFERRED GENERIC NAPROXENTABLETSIBUPROFEN 100/5 ML SUSPENSIONTOPICAL NSAIDSDICLOFENAC GEL 1% PREFERREDWITH PAN/A TOPICALANESTHETICS(OTC)PAIN RELIEF ROLL-ON LIQUIDLIDOCAINE 4% PLUS CREAMALOE/LIDOCAINE 0.5% GELREGENECARE 2% GELPREFERRED N/ALIDODOSE 3% GELREGENECARE SPRAYALOCANE 4% GELAFTERBURN 2.5% GELXOLIDO 2% CREAM BURN RELIEF 0.5% AEROSAL ASPERCREME 4% SPRAYLIDOCAINE 3% CREAMLIDOCAINE 4% CREAMLIDOCAINE 5% CREAMAFTERSUN 0.5% GELLIDOCAINE 4% PADTOPICAL ANESTHETICS(RX)LIDOCAINE 3% CREAMLIDOCAINE 5% OINTMENT NON-PREFERREDOTC LIDOCAINEPRODUCTSRX LIDOCAINE5% PATCH(PA REQUIRED)MISCELLANEOUS ANTICONVULSANTSPREGABALIN 25MG CAPSULEPREGABALIN 50MG CAPSULEPREGABALIN 75MG CAPSULEPREGABALIN 100MG CAPSULEPREGABALIN 150MG CAPSULEPREGABALIN 200MG CAPSULEPREGABALIN 225MG CAPSULEPREGABALIN 300MG CAPSULEPREGABALIN SOL 20MG/MLPREFERREDWITH NO PRIORAUTHORIZATION(PA)N/AATOPICDERMATITIS PIMECROLIMUS 1% CREAMPREFERREDWITH STEPTHERAPY (ST)N/AFIBRATESFENOFIBRATE 130MG CAPSULEFENOFIBRATE 145MG TABLETFENOFIBRIC 35MG TABLETFENOFIBRIC 105MG TABLETFENOFIBRIC 135MG DR CAPSULENON-PREFERREDWITH STFENOFIBRATE134MG, 160MG, 200MG,43MG, 48MG,54 MG,67 MGFENOFIBRIC ACID 45 MGALCOHOL SWABS (MANUFACTURERS) GLOBAL DIABETICRITE AID NON-PREFERREDMANUFACTURERSBD DIABETESDYNAREXHEALTH MARTULTIMEDALCOHOL SWABS (MANUFACTURERS) BD DIABETESDYNAREXHEALTH MARTULTIMEDPREFERRED N/AIRON SUPPLEMENTS (GENERIC OTC)IRON 45MG TABLETSLOW-RELEASE FE 45MG TABLETHEMAX TABLETGENTLE IRON 28MG CAPSULEHIGH POTENCY FE 27MG TABLETNU-IRON 150 150MG CAPSULEABATRON AF TABLETSLOW IRON 50MG TABLETPREFERRED N/AFERGON 27MG TABLETIRON SUPPLEMENTS(BRAND OTC)FOLITAB 500 TABLET IRON 28MG TABLETFERROUS GLUC 324MG TABLETEZFE 200MG CAPSULEFERROUS GLUC TAB 324MGFERROUS SULF 324MG EC TABLETFERRETTS 325MG TABLETFERREX 150MG CAPSULEFERREX 28 MIS FERREX 150 PLUS CAPSULE FERREX 150 FORTE PL CAPSULECHEWABLE IRONPEDIATRIC IRON CHEWABLEFERROUS SUL 220/5ML LIQUIDFERROUS SULF 300/5ML SYRUPFEOSOL 200MG TABLETSLOW RELEASE FE 143MG CRTABLETNON- PREFERRED OTC GENERIC IRONSUPPLEMENTSRX PRODUCTS:HEMATOGEN FA CAPSULEHEMETAB TABLETMULTIGEN TABLETMULTIGEN PLS TABLETMULTIGEN FOLICTABLETFERRAPLUS 90 TABLETTARON FORTE CAPSULEFOLIVANE-F CAPSULEFOLIVANE-PLS CAPSULECENTRATEX CAPSULEIRON SUPPLEMENTS(PRESCRIPTIONSTRENGTH)IFEREX 150 FORTE CAPSULE HEMATOGEN CAPSULE HEMATOGEN FORTE CAPSULE TRICON CAPSULE MYFERON 150 FORTE CAPSULE FERROCITE PLUS TABLET FEROCON CAPSULE PUREVIT DUA FE PLUS CAPSULE HEMATINIC PL VIT/MIN TABLET HEMATINIC/FA TABLET POLY-IRON 150 FORT CAPSULE CORVITA 150 TABLET TRIGELS-F FORTE CAPSULE TL ICON CAPSULE SE-TAN PLUS CAPSULE NON- PREFERRED OTC GENERIC IRON SUPPLEMENTSRX PRODUCTS:HEMATOGEN FA CAPSULE HEMETAB TABLET MULTIGEN TABLET MULTIGEN PLS TABLET MULTIGEN FOLIC TABLET FERRAPLUS 90 TABLETTARON FORTE CAPSULE FOLIVANE-F CAPSULEFOLIVANE-PLS CAPSULE CENTRATEX CAPSULEUM edits — effective for all members no later than February 1, 2020 No changes in preferred/non-preferred status revision or addition to UM edit onlyANDROGENS*JATENZO CAPSULE ADD ST WITH QUANTITY LIMITS (QL)58 MG AND 198 MG QL: 4 PER DAY 237 MG QL: 2 PER DAY ANTICONVULSANTSNAYZILAM SPRAY 5MG ADD PA WITH QLQL: 50 MG PER 30 DAYS ANTICONVULSANTSOXTELLAR XR 150 MGOXTELLAR XR 600 MGREVISED QL LIMIT:150 MG: 3 TABLETS PER DAY 600 MG: 4 TABLETS PER DAYANTINEOPLASTICAGENTSPIQRAY 200 MG TABLETSPIQRAY 250 MG TABLETSPIQRAY 300 MG TABLETSADD PA WITH QL QL: 1 CARTON PER 28 DAYS ANTINEOPLASTICAGENTSXPOVIO PAK 60MGXPOVIO PAK 80MGXPOVIO PAK 100MGADD QL 1 CARTON PER 28 DAYSANTINEOPLASTICAGENTSNUBEQA 300MG TABLET ADD QL 4 TABLETS PER DAY ANTINEOPLASTICAGENTS TURALIO CAP 200MG ADD QL 4 TABLETS PER DAY ANTINEOPLASTICAGENTS PIQRAY 200MG TAB DOSE PIQRAY 300MG TAB DOSE PIQRAY 250MG TAB DOSE REVISE QL1 CARTON PER 28 DAYS CHOLESTEROLAGENTS EZALLOR SPRINKLE 5 MG CAP EZALLOR SPRINKLE 10 MG CAP EZALLOR SPRINKLE 20 MG CAP EZALLOR SPRINKLE 40 MG CAP ADD PA AND QLQL: 1 TABLET PER DAY COPD AGENTS DUAKLIR 400/12 INHALER ADD ST AND QLQL: 1 INHALER PER 30 DAYSCYSTIC FIBROSISAGENTSKALYDECO PAK 25MG ADD QL2 PACKETS PER DAYCYSTIC FIBROSISAGENTSORKAMBI GRANULES ADD QL2 PACKETS PER DAY HIVDOVATO TABLET EDURANT 25 MG TABLET DELSTRIGO TABLET COMPLERA TABLET ODEFSEY TABLET JULUCA TABLET ADD PA FOR NEW STARTS AND ADD QLQL: 1 PER DAY HIVINTELENCE TABLET ADD PA FOR NEW STARTS AND ADD QLQL:200 MG- 2 TABLETS PER DAY 400 MG- 4 TABLETS PER DAY 25 MG – 16 TABLETS PER DAYHIVATRIPLA TABLET BIKTARVY TABLET CIMDUO TABLET DESCOVY TABLETEMTRIVA 200 MG CAPSULE EPIVIR 300 MG TABLET EPZICOM TABLET EVOTAZ TABLET GENVOYA TABLET PIFELTRO 100 MG TABLET PREZCOBIX TABLET PREZISTA 800 MG TABLET REYATAZ 300 MG CAPSULESTRIBILD TABLET SUSTIVA 600 MG TABLETSYMFI TABLET SYMFI LO TABLET SYMTUZA TABLET TRIUMEQ TABLET TRUVADA TABLET TYBOST 150 MG TABLET VIDEX EC 400 MG CAPSULE VIDEX EC 250 MG CAPSULE VIRAMUNE XR 400 MG TABLETADD QL 1 PER DAYTEMIXYS TABLETHIVREYATAZ 200 MG CAPSULE REYATAZ 150 MG CAPSULE VIDEX EC 200 MG CAPSULE ZERIT 40 MG CAPSULE ZERIT 30 MG CAPSULE COMBIVIR TABLET DUTREBIS TABLET EPIVIR 150 MG TABLET ISENTRESS HD 600 MG TABLET PREZISTA 600 MG TABLET RETROVIR 300 MG TABLET SELZENTRY 75 MG TABLET TIVICAY 10 MG, 25 MG AND 50 MGTABLETTRIZIVIR TABLETVIRAMUNE 200 MG TABLET ZIAGEN 300 MG TABLET ADD QL 2 PER DAYHIV ISENTRESS 100 MG GRANULE PACKET FOR SUSPENSION ADD QL2 PACKETS PER DAYHIVVIDEX EC 125 MG CAPSULE VIRAMUNE XR 100MG TABLET ADD QL 3 PER DAYHIVAPTIVUS 250 MG CAPSULE INVIRASE 500 MG TABLET ISENTRESS 400 MG TABLET KALETRA 200 MG-50 MG TABLETLEXIVA 700 MG TABLET SELZENTRY 300 MG TABLET SELZENTRY 150 MG TABLET SUSTIVA 200 MG CAPSULE VIRACEPT 625 MG TABLET ZERIT 20 MG CAPSULE ZERIT 15 MG CAPSULEADD QL 4 PER DAYHIVREYATAZ 50 MG POWDER FORSUSPENSIONADD QL5 PACKETS PER DAYHIVCRIXIVAN 400 MG CAPSULE PREZISTA 150 MG TABLET RESCRIPTOR 200 MG TABLET RETROVIR 100 MG CAPSULE ISENTRESS 100 MG CHEWABLEADD QL 6 PER DAY HIV SELZENTRY 25 MG TABLET ADD QL 8 PER DAY HIV TROGARZO 150MG/ML VIAL ADD QL8 VIALS PER 28 DAYSHIVINVIRASE 200 MG CAPSULE KALETRA 100 MG-25 MG TABLETPREZISTA 75 MG TABLET VIRACEPT 250 MG TABLET ADD QL 10 PER DAY HIVCRIXIVAN 200 MG CAPSULE NORVIR 100 MG TABLET NORVIR 100 MG CAPSULEADD QL 12 PER DAYNORVIR 100 MG ORAL POWDERPACKETRESCRIPTOR 100 MG TABLET SUSTIVA 50 MG CAPSULEHIV APTIVUS 100 MG/ML SOLUTION ADD QL 13 ML PER DAYHIV PREZISTA 100 MG/ML SUSPENSION ADD QL 14 ML PER DAY HIV KALETRA 400 MG-100 MG/5 MLORAL SOLUTIONNORVIR 80 MG/ML ORAL SOLUTION ADD QL 16 ML PER DAY HIV ISENTRESS 25 MG CHEWABLE ADD QL24 TABLETS PER DAYHIV EMTRIVA 10 MG/ML SOLUTION ADD QL 29 ML PER DAYHIVEPIVIR 10 MG/ML ORAL SOLUTION ZIAGEN 20 MG/ML SOLUTION ADD QL 32 ML PER DAY HIVVIDEX 4 GM PEDIATRIC ORALSOLUTIONVIDEX 2 GM PEDIATRIC ORALSOLUTIONVIRAMUNE 50 MG/5 MLSUSPENSION ADD QL 40 ML PER DAY HIV VIRACEPT 50 MG/G POWDERADD QL 53 GM PER DAYHIV FUZEON 90 MG VIAL ADD QL60 VIALS PER 30 DAYSHIV LEXIVA 50 MG/ML SUSPENSION ADD QL 60 ML PER DAYHIV SELZENTRY 20 MG/ML ORALSOLUTION ADD QL 62 ML PER DAYHIV RETROVIR 10 MG/ML SYRUP ADD QL 64 ML PER DAYHIVZERIT 1 MG/ML SOLUTION ADD QL 80 ML PER DAY IRRITABLE BOWEL SYNDROME (IBS)AGENTSZELNORM 6MG TABLET ADD PA AND QL QL 2 TABLETS PER DAY LAMBERT-EATON MYASTHENIC SYNDROME AGENTSRUZURGI 10MG TABLET ADD PA AND QL QL 10 TABLETS PER DAYNARCOTIC ANTAGONISTS SUBLOCADE 100/0.5 INJECTION SUBLOCADE 300/1.5 INJECTION REMOVE PANARCOTIC ANTAGONISTS VIVITROL 380MG INEJCTION REMOVE PA AND ADD QL QL 1 VIAL PER 28 DAYSNARCOTIC ANTAGONISTS ZUBSOLV 2.9-0.71 SUB REVISE QL QL 5 PER DAY ORAL DIABETICAGENTS*QTERNMET XR TABLETADD ST AND QLQL:5 MG/5 MG/1000 MG, 10 MG/5 MG/1000 MG:1 TABLET PER DAY2.5 MG/2.5 MG/1000 MG, 5 MG/2.5 MG/10000MG: 2 TABLETS PER DAYORAL DIABETICAGENTS QTERN 5-5MG TABLET ADD QL1 TABLET 28 DAYSINJECTABLE DIABETIC AGENTSOZEMPIC 2/1.5ML INJECTION ADD QL 1 PER 28 DAYSPRENATAL VITAMINS DUET DHADUET DHA BALANCEDNESTABS ABC NESTABS DHA OBTREX DHA SELECT-OB+DHATHERANATAL COMPLETEVITAFOL FE+ VITAFOL-OB+DHABAL-CARE DHA ESSENTIAL ADD QL 2 PER DAYPRENATAL VITAMINS CITRANATAL B-CALMADD QL 3 PER DAYTOPICAL ANTIPRURITICS DOXEPIN HCL 5% CREAM,ZONALON 5% CREAM, PRUDOXIN5% CREAM ADD PA AND QLQL 1 TUBE PER FILL; 1 FILL PER 3 MONTHSTOPICAL ANESTHETIC COMBINATIONSLIDOCAINE/PRILOCAINE CREAMREVISE QL30 GM PER 30 DAYS* Clinical edits will be put in place as these new drugs to come market.What action do I need to take?Please review these changes and work with your Healthy Connections members to transition them to formulary alternatives. If you determine preferred formulary alternatives are notclinically appropriate for specific members, you will need to obtain prior authorization (PA) to continue coverage beyond the applicable effective date.What if I need assistance?We recognize the unique aspects of member cases. If your Healthy Connections member cannot be converted to a formulary alternative for medical reasons, call our Pharmacy department at 866-902-1689 and follow the voice prompts for pharmacy PA.You can find the Preferred Drug List on our website at > Providers > Pharmacy Information. If you need assistance with any other item, contact the Customer Care Center at 866-757-8286.。

三腾孕化剂501-CS30产品数据资料说明书

Product Data SheetTrigonox 501-CS301,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-3,6,9-tris(Et and Pr) derivs, 30%solution in odorless mineral spiritsTrigonox® 501-CS30 is an initiator for the production of controlled rheology polypropylene (CR-PP) and high-temperature polymerization of ethylene.CAS number1613243-54-1EINECS/ELINCS No.810-295-5TSCA statuslisted on inventorySpecificationsAppearance Clear liquid at 25°CColor40 Pt-Co max.Total active oxygen 5.17-5.48 %CharacteristicsDensity, 20°C0.86 g/cm³ApplicationsTrigonox® 501-CS30 is an efficient peroxide formulation for the production of controlled rheology polypropylene (CR-PP) in an extrusion process. Trigonox® 501-CS30 allows polypropylene producers great flexibility in controlling a polymer’s Melt Flow Index (MFI). Small changes in either peroxide concentration or process temperature can produce significantly different MFI’s. An important advantage of Trigonox® 501-CS30 is that the final CR-PP contains a low content of volatiles originating from peroxide decomposition products. Trigonox® 501-CS30 forms no acetone and no tert-butanol.Half-life dataThe reactivity of an organic peroxide is usually given by its half-life (t1/2) at various temperatures. For Trigonox® 501-CS30 in chlorobenzene half-life at other temperatures can be calculated by using the equations and constants mentioned below:0.1 hr170°C (338°F)1 hr146°C (295°F)10 hr125°C (257°F)Formula 1kd = A·e-Ea/RTFormula 2t½ = (ln2)/kdEa150.60 kJ/moleA 1.09E+15 s-1R8.3142 J/mole·KT(273.15+°C) KThermal stabilityOrganic peroxides are thermally unstable substances, which may undergo self-accelerating decomposition. The lowest temperature at which self-accelerating decomposition of a substance in the original packaging may occur is the Self-Accelerating Decomposition Temperature (SADT). The SADT is determined on the basis of the Heat Accumulation Storage Test.SADT110°C (230°F)Method The Heat Accumulation Storage Test is a recognized test method for thedetermination of the SADT of organic peroxides (see Recommendations on theTransport of Dangerous Goods, Manual of Tests and Criteria - United Nations, NewYork and Geneva).StorageDue to the relatively unstable nature of organic peroxides a loss of quality can be detected over a period of time. To minimize the loss of quality, Nouryon recommends a maximum storage temperature (Ts max. ) for each organic peroxide product.Ts max.40°C (104°F)Ts min.-30°C (-22°F)Note When stored under these recommended storage conditions, Trigonox® 501-CS30 will remain within the Nouryon specifications for a period of at least 12months after delivery.Packaging and transportThe standard packaging is a 770 kg Polyethylene Intermediate Bulk Container (PE IBC). Both packaging and transport meet the international regulations. For the availability of other packed quantities consult your Nouryon representative. Trigonox® 501-CS30 is classified as Organic peroxide type F; liquid, Division 5.2; UN 3109 for land and sea transport and classified as Organic peroxide type C; liquid, Division 5.2; UN 3103 for air transport.Safety and handlingKeep away from open fire, sparks and other sources of heat or ignition. Avoid contact with reducing agents (e.g. amines), acids, alkalis and heavy metal compounds (e.g. accelerators, driers and metal soaps). Please refer to the Safety Data Sheet (SDS) for further information on the safe storage, use and handling of Trigonox® 501-CS30. This information should be thoroughly reviewed prior to acceptance of this product. The SDS is available at /sds-search.Major decomposition productsCarbon dioxide, Methane, Ethane, Propane, Methyl ethyl ketone, Methyl propyl ketone, Methyl acetate, Ethyl acetate, Propyl acetateAll information concerning this product and/or suggestions for handling and use contained herein are offered in good faith and are believed to be reliable.Nouryon, however, makes no warranty as to accuracy and/or sufficiency of such information and/or suggestions, as to the product's merchantability or fitness for any particular purpose, or that any suggested use will not infringe any patent. Nouryon does not accept any liability whatsoever arising out of the use of or reliance on this information, or out of the use or the performance of the product. Nothing contained herein shall be construed as granting or extending any license under any patent. Customer must determine for himself, by preliminary tests or otherwise, the suitability of this product for his purposes.The information contained herein supersedes all previously issued information on the subject matter covered. The customer may forward, distribute, and/or photocopy this document only if unaltered and complete, including all of its headers and footers, and should refrain from any unauthorized use. Don’t copythis document to a website.Trigonox® is a registered trademark of Nouryon Functional Chemicals B.V. or affiliates in one or more territories.Contact UsPolymer Specialties Americas************************Polymer Specialties Europe, Middle East, India and Africa*************************Polymer Specialties Asia Pacific************************2023-6-22© 2023Polymer production Trigonox 501-CS30。

hss-p-5.75.09 - hyaluronic acid derivatives说明书

5.75.09Section:Prescription DrugsEffective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject:Hyaluronic Acid DerivativesPage:1 of 7Last Review Date:March 13, 2020Hyaluronic Acid DerivativesDescriptionDurolane, Euflexxa, GelSyn-3, GenVisc 850, Hyalgan , SodiumHyaluronate, Supartz , Synojoynt*, Triluron, TriVisc, Visco-3 (sodium hyaluronate)Gel-ONE , Hymovis, Monovisc, Orthovisc (hyaluronan)Synvisc, Synvisc-One (hylan G-F 20)Bolded medications are the preferred products*These medications are included in this policy but are not available in the market as of yetBackgroundOsteoarthritis of the knee is a disease in which the elastoviscous property of the synovial fluid in the knee joint becomes diminished, resulting in less protection and shock absorption. Durolane, Euflexxa, Gel-One, GelSyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Sodium Hyaluronate, Synvisc, Synvisc-One, Supartz, Synojoynt, Triluron, TriVisc, Visco-3 are hyaluronan derivatives that are injected into the knee joints to increase the elastoviscous properties of arthritic joint fluid and slow its outflow from the joint . The goal of therapy is torestore the viscoelasticity in the affected joints, thereby decreasing pain, improving mobility, and restoring the natural protective functions (1).The American College of Rheumatology (ACR) updated its guidelines for the treatment of osteoarthritis (OA) of the knee in 2012. In mild symptomatic OA, treatment may be limited toFederal Employee Program® 1310 G Street, N.W.Washington, D.C. 20005 202.942.1000Fax 202.942.1125Section: Prescription Drugs Effective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject: Hyaluronic Acid Derivatives Page: 2 of 7patient education, physical and occupational therapy and other non-pharmacologic modalities. Nonpharmacologic modalities strongly recommended for the management of knee OA were aerobic, aquatic, and/or resistance exercises as well as weight loss for overweight patients. Nonpharmacologic modalities conditionally recommended for knee OA included medial wedge insoles for valgus knee OA, subtalar strapped lateral insoles for varus knee OA, medially directed patellar taping, manual therapy, walking aids, thermal agents, tai chi, self-management programs, and psychosocial interventions. Pharmacologic modalities conditionally recommended for the initial management of patients with knee OA included acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid injections (1).Regulatory StatusFDA-approved indication: Hyaluronic acid derivatives are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy, simple analgesics (e.g., acetaminophen), NSAIDs, tramadol, or intra-articular steroid injections (2-18).The hyaluronic acid derivatives are contraindicated for use in patients with known hypersensitivity to hyaluronan (sodium hyaluronate) preparations. Orthovisc lists hypersensitivity to gram positive bacterial proteins as an additional contraindication (4). Caution should be exercised when Gel-One, Hyalgan, Visco-3, Synvisc, Synvisc-One, Supartz, and Triluron are administered to patients with allergies to avian proteins, feathers, and egg products (3-8, 18).Hyaluronic acid derivatives are contraindicated to treat patients with knee joint infections, infections or skin diseases in the area of the injection site (2-17).A treatment cycle for most of the hyaluronan derivatives typically involves multiple weekly injections. Euflexxa, GelSyn-3, Sodium Hyaluronate, Synvisc, Triluron, TriVisc, and Visco-3 are given for a total of three injections. Orthovisc is given for three or four injections. GenVisc 850, Supartz and Hyalgan are given for a total of three or five injections. Durolane, Gel-One, Synojoynt, and Synvisc-One differ from the other hyaluronan derivatives in that it only requires one injection. Repeat courses of hyaluronan derivatives may be administered if symptoms return (2-18).Upon the basis of high quality supporting evidence, the American Academy of Orthopedic Surgeons cannot recommend using hyaluronic acid for patients with symptomatic osteoarthritis of the knee (19).Related policiesSection: Prescription Drugs Effective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject: Hyaluronic Acid Derivatives Page: 3 of 7Hyaluronate PowderPolicyThis policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims.Hyaluronic acid derivatives may be considered medically necessary for the treatment of osteoarthritis of the knee and if the conditions indicated below are met.Hyaluronic acid derivatives may be considered investigational for all other indications.Prior-Approval RequirementsAge18 years or older (22 or older for Synvisc, Synvisc-One, and TriVisc)DiagnosisPatient must have the following:Osteoarthritis of the kneeAND ALL of the following:1. Inadequate response to TWO or more of the following conservative non-pharmacologic therapy:a. Cardiovascular (aerobic) activity, such as: walking, biking, stationarybike, aquatic exerciseb. Resistance exercisec. Weight reduction (for persons who are overweight)d. Participation in self-management programse. Wear of medially directed patellar tapingf. Wear of wedged insolesg. Thermal agentsh. Walking aidsi. Physical therapyj. Occupational therapy2. Inadequate response, intolerance, or contraindication to TWO or more of thefollowing:Section: Prescription Drugs Effective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject: Hyaluronic Acid Derivatives Page: 4 of 7a. Acetaminophenb. Oral NSAIDsc. Topical NSAIDs3. Inadequate response, intolerance, or contraindication to intra-articularsteroid injections in which efficacy lasted less than 8 weeks4. Radiologic confirmation of Kellgren-Lawrence Scale score of grade 2 orgreater5. NO dual therapy with another hyaluronic acid injectable6. Non-preferred medications only: Patient MUST have tried at least TWO ofthe preferred products unless the patient has a valid medical exception (e.g.inadequate treatment response, intolerance, contraindication)Prior – Approval Renewal RequirementsAge18 years or older (22 or older for Synvisc, Synvisc-One, and TriVisc)DiagnosisPatient must have the following:Osteoarthritis of the kneeAND ALL of the following:1. Documentation of improvement in pain with previous course of treatment2. At least 12 months has elapsed since last injection of the prior treatmentcycle3. Documentation of reduction of dosing of NSAIDs or other analgesicsduring the 12 month period following the last injection of the prior treatmentcycle4. NO dual therapy with another hyaluronic acid injectable5. Non-preferred medications only: Patient MUST have tried at least TWOof the preferred products unless the patient has a valid medical exception(e.g. inadequate treatment response, intolerance, contraindication) Policy GuidelinesPre - PA AllowanceNoneSection: Prescription Drugs Effective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject: Hyaluronic Acid Derivatives Page: 5 of 7Prior - Approval LimitsDuration12 monthsQuantity One course of therapy for each kneePrior – Approval Renewal LimitsSame as aboveRationaleSummaryOsteoarthritis of the knee is a disease in which the elastoviscous property of the synovial fluid in the knee joint becomes diminished, resulting in less protection and shock absorption. Durolane, Euflexxa, Gel-One, GelSyn-3, GenVisc 850, Hyalgan, Hymovis, Monovisc, Orthovisc, Sodium Hyaluronate, Synvisc, Synvisc-One, Supartz, Synojoynt, Triluron, TriVisc, Visco-3 are hyaluronan derivatives that are injected into the knee joints to increase the elastoviscous properties of arthritic joint fluid and slow its outflow from the joint. The goal of therapy is to restore the viscoelasticity in the affected joints, thereby decreasing pain, improving mobility, and restoring the natural protective functions (1-18).Prior approval is required to ensure the safe, clinically appropriate and cost effective use of the hyaluronic acid derivatives while maintaining optimal therapeutic outcomes.References1. American College of Rheumatology, Subcommittee on Osteoarthritis Guidelines.Recommendations for the medical management of osteoarthritis of the hip and knee:2012 update. Arthritis Care & Research 2012; 64(4):465-474.2. Euflexxa [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.; July 2016.3. Hyalgan [package insert]. Parsippany, NJ: Fidia Pharma USA Inc.; May 2014.4. Orthovisc [package insert]. Woburn, MA: Anika Therapeutics; June 2005.5. Supartz [package insert]. Durham, NC: Bioventus LLC; April 2015.6. Synvisc [package insert]. Ridgefield, NJ: Genzyme Corp.; December 2014.7. Synvisc-One [package insert]. Ridgefield, NJ: Genzyme Corp.; September 2014;8. Gel-One [package insert]. Warsaw, IN: Zimmer Inc.; May 2011.9. Monovisc [package insert]. Bedford, MA: Anika Therapeutics; December 2013.10. Hymovis [package insert]. Parsippany, NJ: O Fidia Pharma USA Inc.; October 2015.Section: Prescription Drugs Effective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject: Hyaluronic Acid Derivatives Page: 6 of 711. GenVisc 850 [package insert]. Doylestown, PA: OrthogenRx Inc.; January 2015.12. GelSyn-3 [package insert]. Durham, NC: Bioventus LLC; January 2016.13. Durolane [package insert]. Durham, NC: Bioventus LLC; November 2017.14. Visco-3 [package insert]. Warsaw, IN: Zimmer, Inc.; May 2017.15. Sodium Hyaluronate [package insert]. North Wales, PA: Teva Pharmaceuticals USA,Inc.; March 2019.16. Synojoynt [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.;September 2019.17. TriVisc [package insert]. Doylestown, PA: OrthogenRx, Inc.; September 2018.18. Triluron [package insert]. Florham Park, NJ: Fidia Pharma USA Inc.; March 2019.19. American Academy of Orthopaedic Surgeons. Treatment of osteoarthritis of the knee.Evidence-based guideline 2nd edition. May 2013.Policy HistoryDate Action ReasonJanuary 2012 Added minimum age - only approved for adultsDecember 2012 Annual editorial review and reference updateDecember 2013 Annual editorial review and reference updateMarch 2014 Annual editorial reviewAddition of examples of non-pharmacological agents and agents of priorfailure medications.April 2014 Line-Addition of Monovisc to PAMarch 2015 Annual criteria review and reference updateMarch 2016 Change from one tried and failed to two tried and failed non-pharmacologic and pharmacologic therapies and addition of the tried and failed of intra-articular steroid and radiologic confirmation of Kellgren-Lawrence Scalescore of grade 2 or greaterAddition of HymovisPolicy # change from 5.11.04 to 5.75.09May 2016 Addition of GelSyn-3 and GenVisc 850December 2016 Annual editorial review and reference updateAdded: no dual therapy with another hyaluronic acid injectableMarch 2017 Bolded preferred products in the title pageJuly 2017 GelSyn-3 has been changed to preferredSeptember 2017 Annual reviewDecember 2017 Addition of Durolane and Visco-3March 2018 Annual editorial reviewRemoval of Tramadol from the T/F listSeptember 2019 Annual review and reference update. Addition of Sodium Hyaluronate,Synojoynt, and TriViscSection: Prescription Drugs Effective Date: April 1, 2020 Subsection: Neuromuscular Drugs Original Policy Date: June 9, 2011 Subject: Hyaluronic Acid Derivatives Page: 7 of 7December 2019 Annual review. Addition of requirement to trial preferred products January 2020 Addition of TriluronMarch 2020 Annual reviewKeywordsThis policy was approved by the FEP® Pharmacy and Medical Policy Committee on March 13, 2020 and is effective on April 1, 2020.。

人促肾上皮质激素释放激素(CRH)ELISA试剂盒说明书

人促肾上皮质激素释放激素(CRH)酶联免疫分析试剂盒使用说明书厦门慧嘉生物科技有限公司本试剂仅供研究使用目的：本试剂盒用于测定人血清，血浆及相关液体样本中促肾上皮质激素释放激素(CRH)的含量。

实验原理：本试剂盒应用双抗体夹心法测定标本中人促肾上皮质激素释放激素(CRH)水平。

用纯化的人促肾上皮质激素释放激素(CRH)抗体包被微孔板，制成固相抗体，往包被单抗的微孔中依次加入促肾上皮质激素释放激素(CRH)，再与HRP标记的羊抗人抗体结合，形成抗体-抗原-酶标抗体复合物，经过彻底洗涤后加底物TMB显色。

TMB在HRP酶的催化下转化成蓝色，并在酸的作用下转化成最终的黄色。

颜色的深浅和样品中的促肾上皮质激素释放激素(CRH)呈正相关。

用酶标仪在450nm波长下测定吸光度（OD值），通过标准曲线计算样品中人促肾上皮质激素释放激素(CRH)浓度。

试剂盒组成：样本处理及要求：1. 血清：室温血液自然凝固10-20分钟，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如出现沉淀，应再次离心。

2. 血浆：应根据标本的要求选择EDTA或柠檬酸钠作为抗凝剂，混合10-20分钟后，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如有沉淀形成，应该再次离心。

3. 尿液：用无菌管收集，离心20分钟左右（2000-3000转/分）。

仔细收集上清，保存过程中如有沉淀形成，应再次离心。

胸腹水、脑脊液参照实行。

4. 细胞培养上清：检测分泌性的成份时，用无菌管收集。

离心20分钟左右（2000-3000转/分）。

仔细收集上清。

检测细胞内的成份时，用PBS（PH7.2-7.4）稀释细胞悬液，细胞浓度达到100万/ml左右。

通过反复冻融，以使细胞破坏并放出细胞内成份。

离心20分钟左右（2000-3000转/分）。

仔细收集上清。

保存过程中如有沉淀形成，应再次离心。

5. 组织标本：切割标本后，称取重量。

FDA批准的精准医疗诊断体外器械一览表List of Cleared or Approved Companion Diagnostic Devices

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools)
Drug Trade Name
NDA/BLA
Device Trade Name
PMA
Device Manufacturer
Intended Use (IU)/ Indications for Use (IFU)
(imatinibmesylate)
NDA 021588
The c-KitpharmDxis indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-KitpharmDxmay be used as an aid in identifying those patients eligible for treatment withGleevec/Glivec(imatinibmesylate).
(deferasirox)
Gilotrif
NDA 201292
therascreenEGFR RGQ PCR Kit
P120022
QiagenManchester, Ltd.
ThetherascreenEGFR RGQ PCR Kit is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used to select patients with NSCLC for whom GILOTRIF (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated. Safety and efficacy of GILOTRIF (afatinib) have not been established in patients whose tumors have L861Q, G719X, S768I, exon 20 insertions, and T790M mutations, which are also detected by thetherascreenEGFR RGQ PCR Kit.

M5 鲑鱼精 DNA 10mg ml 说明书

北京聚合美生物科技有限公司 Mei5 Biotechnology, Co., Ltd
北京市昌平区回龙观龙域北街10号院1号楼四层422-1室（创集合大楼）热线电话：（86）************
M5 鲑鱼精DNA 10mg/ml 使用说明书
产品名称单位货号 M5 鲑鱼精DNA 10mg/ml 1 ml MF475-01 M5 鲑鱼精DNA 10mg/ml 5x1 ml MF475-05
【储存条件】
-20℃保存，有效期2年。

【产品简介】
鲑鱼精DNA 溶液（10mg/ml ）是经过酚氯仿抽提，超声和热变性处理的短片段的单链DNA 溶液，可直接用于Southern 、Northern 等核酸杂交中。

【操作步骤】
本产品鲑鱼精DNA 的浓度为10mg/ml ，使用时按实验具体要求操作，稀释至所需工作浓度即可。

【注意事项】
1. 如果每次的使用量很小，可以适当分装后再使用，避免反复冻融。

2. 为了您的安全和健康，请穿实验服并戴手套操作。

【备注】
本产品仅供科研使用。

在确认产品质量出现问题时，本公司承诺为客户免费更换等量的质量合格产品。

美国贝克曼库尔特流式细胞分析仪

美国贝克曼库尔特流式细胞分析仪（Beckman coulter cell）产品型号：Cell Lab Quanta SC当前价格：0.00元产品数量：0新旧程度：全新有效期至：0000-00-00所在地：产品简介：仪器简介：T细胞亚群检测的CD45/CD4/CD8/CD3、CD45/CD56/CD19/CD3；阵发性血红蛋白尿（PNH）检测的CD55、CD59；血小板无力症（GT）检测的CD41、CD61等等详细信息仪器简介：T细胞亚群检测的CD45/CD4/CD8/CD3、CD45/CD56/CD19/CD3；阵发性血红蛋白尿（PNH）检测的CD55、CD59；血小板无力症（GT）检测的CD41、CD61等等。

但对于白血病/淋巴瘤免疫分型，国际上迄今为止也没有统一的抗体组合。

在2000年国际细胞分析学会（ISAC）大会上，临床血细胞计数协会组织了一次国际专家会议，以期对检测血液淋巴系统肿瘤所需最少、最有效的单抗数达成共识。

75%与会者一致认为，对于慢性淋巴系统增殖性疾病（CLD）有9种单抗：CD5,CD19,κ,λ,CD3,CD20,CD23,CD10,CD45对初诊来说是最基本的。

淋巴瘤和CLD相似，需要至少12-16种单抗。

对于急性白血病（AL），75%的与会者认为大约13-15种单抗是最基本的：CD10,CD19,CD79a,CD13,CD33,CD34,CD45,CD2,MPO，CD7,CD14,CD3,HLA-DR等，对初步鉴别白血病系列是必需的。

其他一些（CD16,CD56,CDw65,TdT,cyCD3）可能对某些病例有用。

几乎所有的投票者都认为，要对急性白血病完善分类所需单抗的恰当数量平均为20-24种。

但这些抗体之间组合也是一大难题，目前也无统一规定（如表二）。

大会多数发言者(11/13)指出，对已确诊病人的监护和分期来说，仅需较少单抗。

抗体的质量控制是实验的关键环节。

抗体的质量包括其特异性、灵敏度、精密度。

循能泰说明书(己酮可可碱外文说明书)

OCH CCH CH CH CH 32223 TRENTAL ®(pentoxifylline)Tablets, 400 mg DESCRIPTIONTRENTAL ® (pentoxifylline) tablets for oral administration contain 400 mg of the active drugand the following inactive ingredients: FD&C Red No. 3, hypromellose USP, magnesium stearate NF, polyethylene glycol NF, povidone USP, talc USP, titanium dioxide USP, andhydroxyethyl cellulose USP in an extended-release formulation. TRENTAL is a tri-substitutedxanthine derivative designated chemically as 1-(5-oxohexyl)-3, 7-dimethylxanthine that, unliketheophylline, is a hemorrheologic agent, i.e. an agent that affects blood viscosity. Pentoxifyllineis soluble in water and ethanol, and sparingly soluble in toluene. The CAS Registry Number is6493-05-6.The chemical structure is:CLINICAL PHARMACOLOGYMode of ActionPentoxifylline and its metabolites improve the flow properties of blood by decreasing itsviscosity. In patients with chronic peripheral arterial disease, this increases blood flow to theaffected microcirculation and enhances tissue oxygenation. The precise mode of action ofpentoxifylline and the sequence of events leading to clinical improvement are still to be defined.Pentoxifylline administration has been shown to produce dose-related hemorrheologic effects,lowering blood viscosity, and improving erythrocyte flexibility. Leukocyte properties of hemorrheologic importance have been modified in animal and in vitro human studies.Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophiladhesion and activation. Tissue oxygen levels have been shown to be significantly increased bytherapeutic doses of pentoxifylline in patients with peripheral arterial disease.Pharmacokinetics and MetabolismAfter oral administration in aqueous solution pentoxifylline is almost completely absorbed. Itundergoes a first-pass effect and the various metabolites appear in plasma very soon after dosing.Peak plasma levels of the parent compound and its metabolites are reached within 1 hour. Themajor metabolites are Metabolite l (1-[5-hydroxyhexyl]-3,7-dimethylxanthine) and Metabolite V(1-[3-carboxypropyl]-3,7-dimethylxanthine), and plasma levels of these metabolites are 5 and 8times greater, respectively, than pentoxifylline.Following oral administration of aqueous solutions containing 100 to 400 mg of pentoxifylline, the pharmacokinetics of the parent compound and Metabolite l are dose-related and not proportional (non-linear), with half-life and area under the blood-level time curve (AUC) increasing with dose. The elimination kinetics of Metabolite V are not dose-dependent. The apparent plasma half-life of pentoxifylline varies from 0.4 to 0.8 hours and the apparent plasma half-lives of its metabolites vary from 1 to 1.6 hours. There is no evidence of accumulation or enzyme induction (Cytochrome P450) following multiple oral doses.Excretion is almost totally urinary; the main biotransformation product is Metabolite V. Essentially no parent drug is found in the urine. Despite large variations in plasma levels of parent compound and its metabolites, the urinary recovery of Metabolite V is consistent and shows dose proportionality. Less than 4% of the administered dose is recovered in feces. Food intake shortly before dosing delays absorption of an immediate-release dosage form but does not affect total absorption. The pharmacokinetics and metabolism of TRENTAL have not been studied in patients with renal and/or hepatic dysfunction. The pentoxifylline AUC was increased and elimination rate decreased in an older population (60-68 years, n=6) compared to younger individuals (22-30 years, n=6) (see PRECAUTIONS, Geriatric Use).After administration of the 400 mg extended-release TRENTAL tablet, plasma levels of the parent compound and its metabolites reach their maximum within 2 to 4 hours and remain constant over an extended period of time. Coadministration of TRENTAL tablets with meals resulted in an increase in mean C max and AUC by about 28% and 13% for pentoxifylline, respectively. C max for Metabolite 1 also increased by about 20%. The extended release of pentoxifylline from the tablet eliminates peaks and troughs in plasma levels for improved gastrointestinal tolerance.INDICATIONS AND USAGETRENTAL is indicated for the treatment of patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. TRENTAL can improve function and symptoms but is not intended to replace more definitive therapy, such as surgical bypass, or removal of arterial obstructions when treating peripheral vascular disease.CONTRAINDICATIONSTRENTAL should not be used in patients with recent cerebral and/or retinal hemorrhage or in patients who have previously exhibited intolerance to this product or methylxanthines such as caffeine, theophylline, and theobromine.PRECAUTIONSGeneralAt the first sign of anaphylactic/anaphylactoid reaction, TRENTAL must be discontinued.Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. TRENTAL has been used safely for treatment of peripheral arterial disease in patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia. Controlled trials do not show that TRENTAL causes such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible some individuals will experience such responses. Patients on Warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration, cerebral and/or retinal bleeding) should have periodic examinations for bleeding including, hematocrit and/or hemoglobin.Drug InteractionsAlthough a causal relationship has not been established, there have been reports of bleedingand/or prolonged prothrombin time in patients treated with TRENTAL with and without anticoagulants or platelet aggregation inhibitors. Patients on Warfarin should have more frequent monitoring of prothrombin times, while patients with other risk factors complicated by hemorrhage (e.g., recent surgery, peptic ulceration) should have periodic examinations for bleeding including hematocrit and/or hemoglobin.Concomitant administration of TRENTAL and theophylline-containing drugs leads to increased theophylline levels and theophylline toxicity in some individuals. Such patients should be closely monitored for signs of toxicity and have their theophylline dosage adjusted as necessary.TRENTAL has been used concurrently with beta blockers, digitalis, diuretics, antidiabetic agents, and antiarrhythmics, without observed problems. Small decreases in blood pressure have been observed in some patients treated with TRENTAL plus nifedipine or captopril; periodic systemic blood pressure monitoring is recommended for patients receiving concomitant antihypertensive therapy. If indicated, dosage of the antihypertensive agents should be reduced.Postmarketing cases of increased anticoagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anticoagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.Carcinogenesis, Mutagenesis and Impairment of FertilityLong-term studies of the carcinogenic potential of pentoxifylline were conducted in mice and rats by dietary administration of the drug at doses up to 450 mg/kg (approximately 19 times the maximum recommended human daily dose (MRHD) in both species when based on body weight; 1.5 times the MRHD in the mouse and 3.3 times the MRHD in the rat when based on body surface area). In mice, the drug was administered for 18 months, whereas in rats, the drug was administered for 18 months followed by an additional 6 months without drug exposure. In the rat study, there was a statistically significant increase in benign mammary fibroadenomas in females of the 450 mg/kg group. The relevance of this finding to human use is uncertain. Pentoxifylline was devoid of mutagenic activity in various strains of Salmonella (Ames test) andin cultured mammalian cells (unscheduled DNA synthesis test) when tested in the presence and absence of metabolic activation. It was also negative in the in vivo mouse micronucleus test. PregnancyCategory C. Teratogenicity studies have been performed in rats and rabbits using oral doses up to 576 and 264 mg/kg, respectively. On a weight basis, these doses are 24 and 11 times the maximum recommended human daily dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5 times the MRHD. No evidence of fetal malformation was observed. Increased resorption was seen in rats of the 576 mg/kg group. There are no adequate and well controlled studies in pregnant women. TRENTAL (pentoxifylline) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing MothersPentoxifylline and its metabolites are excreted in human milk. Because of the potential for tumorigenicity shown for pentoxifylline in rats, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.Pediatric UseSafety and effectiveness in pediatric patients have not been established.Geriatric UseClinical studies of TRENTAL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.The active metabolite is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.ADVERSE REACTIONSClinical trials were conducted using either extended-release TRENTAL tablets for up to 60 weeks or immediate-release TRENTAL capsules for up to 24 weeks. Dosage ranges in the tablet studies were 400 mg bid to tid and in the capsule studies, 200-400 mg tid. The table summarizes the incidence (in percent) of adverse reactions considered drug related, as well as the numbers of patients who received extended-release TRENTAL tablets, immediate-release TRENTAL capsules, or the corresponding placebos. The incidence of adverse reactions was higher in thecapsule studies (where dose related increases were seen in digestive and nervous system side effects) than in the tablet studies. Studies with the capsule include domestic experience, whereas studies with the extended-release tablets were conducted outside the U.S.The table indicates that in the tablet studies few patients discontinued because of adverse effects.INCIDENCE (%) OF SIDE EFFECTSExtended-Release Tablets Immediate-Release CapsulesCommercially Available Used only for Controlled ClinicalTrialsTRENTAL Placebo TRENTAL Placebo(Numbers of Patients at Risk) (321) (128) (177) (138)Discontinued for Side Effect 3.1 0 9.6 7.2CARDIOVASCULAR SYSTEMAngina/Chest Pain 0.3 - 1.1 2.2Arrhythmia/Palpitation -- 1.7 0.7Flushing -- 2.30.7 DIGESTIVE SYSTEMAbdominal Discomfort -- 4.0 1.4Belching/Flatus/Bloating 0.6 -9.0 3.62.9 Diarrhea --3.49.62.94.7Dyspepsia 2.88.728.80.8Nausea 2.20.7 Vomiting 1.2- 4.5NERVOUS SYSTEMAgitation/Nervousness -- 1.7 0.74.311.93.1Dizziness 1.95.8 Drowsiness -- 1.1Headache 1.2 1.6 6.2 5.82.2 Insomnia -- 2.3-0.8Tremor 0.3Blurred Vision -- 2.3 1.4TRENTAL has been marketed in Europe and elsewhere since 1972. In addition to the abovesymptoms, the following have been reported spontaneously since marketing or occurred in otherclinical trials with an incidence of less than 1%; the causal relationship was uncertain:Cardiovascular - dyspnea, edema, hypotension.Digestive - anorexia, cholecystitis, constipation, dry mouth/thirst.Nervous - anxiety, confusion, depression, seizures, aseptic meningitis.Respiratory - epistaxis, flu-like symptoms, laryngitis, nasal congestion.Skin and Appendages - brittle fingernails, pruritus, rash, urticaria, angioedema.Special Senses - blurred vision, conjunctivitis, earache, scotoma.Miscellaneous - bad taste, excessive salivation, leukopenia, malaise, sore throat/swollenneck glands, weight change.A few rare events have been reported spontaneously worldwide since marketing in 1972.Although they occurred under circumstances in which a causal relationship with pentoxifyllinecould not be established, they are listed to serve as information for physicians. Cardiovascular —angina, arrhythmia, tachycardia. Digestive — hepatitis, jaundice, cholestasis, increased liverenzymes; and Hemic and Lymphatic — decreased serum fibrinogen, pancytopenia, aplastic anemia, leukemia, purpura, thrombocytopenia. Immune system disorders — anaphylactic reaction, anaphylactoid reaction, anaphylactic shock.OVERDOSAGEOverdosage with TRENTAL has been reported in pediatric patients and adults. Symptoms appear to be dose related. A report from a poison control center on 44 patients taking overdoses of enteric-coated pentoxifylline tablets noted that symptoms usually occurred 4-5 hours after ingestion and lasted about 12 hours. The highest amount ingested was 80 mg/kg; flushing, hypotension, convulsions, somnolence, loss of consciousness, fever, and agitation occurred. All patients recovered. In addition to symptomatic treatment and gastric lavage, special attention must be given to supporting respiration, maintaining systemic blood pressure, and controlling convulsions. Activated charcoal has been used to absorb pentoxifylline in patients who have overdosed.DOSAGE AND ADMINISTRATIONThe usual dosage of TRENTAL in extended-release tablet form is one tablet (400 mg) three times a day with meals.While the effect of TRENTAL may be seen within 2 to 4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double-blind clinical studies of 6 months duration.Digestive and central nervous system side effects are dose related. If patients develop these effects it is recommended that the dosage be lowered to one tablet twice a day (800 mg/day). If side effects persist at this lower dosage, the administration of TRENTAL should be discontinued.HOW SUPPLIEDTRENTAL (pentoxifylline) is available for oral administration as 400-mg pink film-coated oblong tablets imprinted Trental; supplied in bottles of 100 (NDC 0039-0078-10).Store between 59 and 86° F (15 and 30° C).Dispense in well-closed, light-resistant containers.Rx onlyRev. July 2010sanofi-aventis U.S. LLCBridgewater, NJ 08807©2010 sanofi-aventis U.S. LLC。

安捷伦产品目录

15
Real-Time PCR
16
Mx3000P QPCR System
17
Brilliant III Ultra-Fast SYBR Green QPCR and QRT-PCR Reagents
18
Brilliant III Ultra-Fast QPCR and QRT-PCR Reagents
Agilent / STRATAGENE
Agilent website: /genomics
Welgene | Agilent Stratagene
威健股份有限公司 | Stratagene 總代理
Table of Content
Table of Contents
/ XL1-Red Competent Cells SoloPack Gold Supercompetent Cells
/ TK Competent Cells Specialty Cells
/ Classic Cells / Fine Chemicals For Competent Cells
適用於 UNG 去汙染或 bisulphite
sequencing
適用於 TA Cloning
最高敏感性
取代傳統 Taq 的好選擇
-
2
威健股份有限公司 | Stratagene 總代理
PCR Enzyme & Instrument
Agilent SureCycler 8800
市場上領先的 cycling 速度和 sample 體積 10 ～ 100 μL 簡易快速可以選擇 96 well 和 384 well 操作盤優秀的溫控設備讓各個 well 都能保持溫度的穩定七吋的高解析度觸控螢幕讓操作上更為簡便可以透過網路遠端操控儀器及監控儀器 Agilent 專業的技術支援可以幫助您應對各種 PCR 的問題

GC测定盐酸普拉克索中三乙胺残留量

ABSTRACT: OBJECTIVE To determine the triethylamine in pramipexole hydrochloride by GC. METHODS The residual triethylamine was determined by HS-GC with Agilent-INNOWAX capillary column(30 m×0.32 mm, 0.5 μm) and FID detector. The carrier gas was nitrogen and the flow rate was 4.0 mL·min1. The temperature of the injection port was maintaining at 250 ℃ and the same of detector. The oven introduced sequential increasing of temperature programing. The initial column temperature was 50 ℃, then raised the temperature to 150℃ at a rate of 10 ℃·min1, and maintained it at 150 ℃ for 5 min, then raised the temperature to 220 ℃ at a rate of 40 ℃·min1, and maintained it for 5 min. The headspace oven was set at a temperature of 80 ℃ for 30 min. The solvent was 20% sodium hydroxide solution. The triethylamine was quantified external standard. RESULTS The calibration shows a good linearity with the range of 0.31712.68 μg·mL1 for triethylamine. The average recovery was 97.9%(n=9). The precision was 4.18%(n=9). CONCLUSION This method is accurate, reliable and sensitive for the

布鲁氏菌恒温扩增核酸试纸条检测试剂盒说明书

布鲁氏菌恒温扩增核酸试纸条检测试剂盒说明书【产品名称】布鲁氏菌恒温扩增核酸试纸条检测试剂盒【英文名称】Brucella Isothermal Amplification Diagnostic Kit 【包装规格】单管单人份，20人份/盒。

【预期用途】用于布鲁氏菌的快速检测和筛查。

仅供科研。

【检验原理】本试剂盒将DNA 扩增、核酸杂交和核酸试纸条检测三种技术有机地融为一体，在反应中加入两对布鲁氏菌的特异性引物和一对特异性探针，一次性完成DNA 扩增及杂交过程，然后用一次性核酸检测装置（3号）对布鲁氏菌进行定性检测。

由于待测样本的扩增（PCR 管盖和石蜡油双重保护）和检测过程均在物理封闭条件下完成，所以本试剂盒具有防止实验室扩增物交叉污染，防止假阳性的效果。

【试剂盒组成】 1 试剂盒A*不带标签，反应管中包括除样本外的所有试剂。

上覆矿物油，以防止扩增中产生气溶胶，防止假阳性。

2 试剂盒B【储运条件及有效期】1.运输条件：试剂盒A 需要-20℃冷冻运输，运输过程中，试剂盒A 在-20℃-0℃内保存时间不超过五天；试剂盒B 可以常温运输。

2.储存条件：试剂盒A 在-20℃保存；试剂盒B 在2℃-30℃保存。

3.有效期：有效期12个月【仪器及物品要求】恒温装置如：水浴锅、金属浴、各种型号PCR 仪等。

【操作步骤】1 样本处理及DNA 提取未提供 2 恒温扩增2.1 根据需要确定所需反应液的管数，然后从试剂盒中取出反应管并做上标记； 2.2 待反应液解冻后，以>4000rpm 的转速离心3-5秒；2.3 在任何样本被加入之前，首先在一管反应液中直接加入10ul ddH 2O，用移液器吹打混匀，作为阴性对照； 2.4 在其余标记好的反应管中，依次加入6ul ddH 2O 和4ul 处理好的样本或阳性对照（试剂盒中提供），并用移液器吹打混匀（阳性对照应在阴性对照和所有样品之后被加入）； 2.5 将加好样的反应液以>4000rpm 的转速再离心3-5秒；2.6 将反应管放置恒温仪上，60℃温浴60min （在温浴过程中和温浴结束后不得打开反应管盖）。

重组贻贝粘蛋白的表征及功效评价

生物技术进展 2023 年第 13 卷第 4 期 596 ~ 603Current Biotechnology ISSN 2095‑2341研究论文Articles重组贻贝粘蛋白的表征及功效评价李敏，魏文培，乔莎，郝东，周浩，赵硕文，张立峰，侯增淼 *西安德诺海思医疗科技有限公司，西安 710000摘要：为了推进重组贻贝粘蛋白在医疗、化妆品领域的应用，对大肠杆菌规模化发酵及纯化生产获得的重组贻贝粘蛋白进行了表征及功效评价。

经Edman 降解法、基质辅助激光解吸电离飞行时间质谱、PITC 法、非还原型SDS -聚丙烯酰胺凝胶电泳法、凝胶法、改良的Arnow 法对重组贻贝粘蛋白进行氨基酸N 端测序、相对分子量分析、氨基酸组成分析、蛋白纯度分析、内毒素含量测定、多巴含量测定；通过细胞迁移、斑马鱼尾鳍修复效果对重组贻贝粘蛋白进行功效评价。

结果显示，获得的重组贻贝粘蛋白与理论的一级结构一致，蛋白纯度达95%以上，内毒素<10 EU ·mg -1,多巴含量大于5%；重组贻贝粘蛋白浓度为60 μg ·mL -1时能够显著促进细胞增殖的活性（P <0.01）；斑马鱼尾鳍面积样品组与模型对照组相比极显著增加（P <0.001）。

研究结果表明，重组贻贝粘蛋白具有显著的促细胞迁移和修复愈合的功效，具备作为生物医学材料的潜质。

关键词：贻贝粘蛋白；基因重组；生物材料；表征；功效评价DOI ：10.19586/j.20952341.2023.0021 中图分类号：S985.3+1 文献标志码：ACharacterization and Efficacy Evaluation of Recombinant Mussel Adhesive ProteinLI Min ， WEI Wenpei ， QIAO Sha ， HAO Dong ， ZHOU Hao ， ZHAO Shuowen ， ZHANG Lifeng ，HOU Zengmiao *Xi'an DeNovo Hith Medical Technology Co.， Ltd ， Xi'an 710000， ChinaAbstract ：In order to promote the application of recombinant mussel adhesive protein in the medical and cosmetics field ， the recombi⁃nant mussel adhesive protein obtained from scale fermentation and purification of Escherichia coli was characterized and its efficacy was evaluated. Amino acid N -terminal sequencing ， relative molecular weight analysis ， amino acid composition analysis ， protein purityanalysis ， endotoxin content ， dihydroxyphenylalanine （DOPA ） content of recombinant mussel adhesive protein were determined by the following methods ： Edman degradation ， matrix -assisted laser desorption ionization time -of -flight mass spectrometry （MALDI -TOF -MS ）， phenyl -isothiocyanate （PITC ）， nonreductive SDS -polyacrylamide gel electrophoresis （SDS -PAGE ）， gel method ， modified Ar⁃now. The efficacy of recombinant mussel adhesive protein was evaluated by cell migration and repairing effect of zebrafish tail fin. Re⁃sults showed that the obtained recombinant mussel adhesive protein was confirmed to be consistent with the theoretical primary structure ， protein purity of more than 95%， endotoxin <10 EU ·mg -1， DOPA content above 5%. When the recombinant mussel adhesive protein concentration was 60 μg ·mL -1， the effect of promoting cell proliferation was the most obvious ， and it had very significant activity （P <0.01）. The caudal fin area of zebrafish in sample group was significantly increased compared with model control group （P <0.001）. The results indicated that recombinant mussel adhesive protein can promote cell migration and repair healing and has the potential to be used as biomedical materials.Key words ：mussel adhesive protein ； gene recombination ； biological materials ； representation ； efficacy evaluation贻贝粘蛋白（mussel adhesive protein ， MAP ）也称作贻贝足丝蛋白（mussel foot protein ，Mfps ），收稿日期：2023⁃02⁃24；接受日期：2023⁃03⁃31联系方式：李敏 E -mail:*******************;*通信作者侯增淼 E -mail:***********************.cn李敏，等：重组贻贝粘蛋白的表征及功效评价是海洋贝类——紫贻贝（Mytilus galloprovincalis）、厚壳贻贝（Mytilus coruscus）、翡翠贻贝（Perna viri⁃dis）等分泌的一种特殊的蛋白质，贻贝中含有多种贻贝粘蛋白，包括贻贝粘蛋白（Mfp 1～6）、前胶原蛋白（precollagens）和基质蛋白（matrix proteins）等［1］。

进口器械耗材试剂目录表1

1.乳酸脱氢酶试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2002.肌酸激酶试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400291号(更3.碱性磷酸酶试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400293号(4.丙氨酸氨基转移酶试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第34005.淀粉酶试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400294号(更))6.CD45RO-PE荧光单克隆抗体试剂 (法国 IMMUNOTECH S.A.S （美国贝克曼库尔特有限公司分公司）国7.CD3-FITC/CD(16+56)-PE荧光单克隆抗体试剂 (法国 IMMUNOTECH S.A.S （美国贝克曼库尔特有限公司8.CD45RA-FITC荧光单克隆抗体试剂 (法国 IMMUNOTECH S.A.S （美国贝克曼库尔特有限公司分公司）9.ISE－缓冲液 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400162号(更))10.稀释液 ( 国食药监械（进）字2007第3400992号)11.质控品 (美国SYSMEX CORPORATION希森美康株式会社国食药监械（进）字2007第3400993号)12.质控品 (美国 SYSMEX CORPORATION希森美康株式会社国食药监械（进）字2007第3400994号)13.皮质醇试剂包 ( 国食药监械（进）字2007第3401009号)14.三碘甲状腺原氨酸摄取试剂包 (Ortho-Clinical Diagnostics Inc., 国食药监械（进）字2007第3415.肌酸激酶MB亚单位质量试剂包 ( 国食药监械（进）字2007第3401011号)16.采血针 (德国罗氏诊断有限公司国食药监械（进）字2007第3410922号)17.苯妥英试剂盒 ( 国食药监械(进)字2005第3401316号(更))18.凝血酶原时间测试试剂 (德国 Dade Behring Marburg公司国食药监械（进）字2007第3400990号)19.GPA-PE荧光单克隆抗体试剂 (法国 IMMUNOTECH S.A.S （美国贝克曼库尔特有限公司分公司）国食20.腔镜手助器(商品名：兰碟斯) (Hakko Co., Ltd. 国食药监械(进)字2007第3660631号)21.高压注射连接管 (美国 Argon Medical Devices, Inc 国食药监械(进)字2007第3660652号)22.球囊扩张导管(商品名：Extensor) ( 国食药监械(进)字2007第3770536号)23.弹簧圈(商品名：GDC) (Boston Scientific Corporation 国食药监械(进)字2007第3770569号)24.穿刺导引套装英文名称：Exacta Percutaneous Sheath Introducer Kits (Becton Dickinson Cri25.7.382缓冲液 ( 国食药监械(进)字2004第3401401号(更))26.尿液总蛋白试剂盒 ( 国食药监械(进)字2005第3401707号(更))27.网织红细胞稀释液·染色液 (日本 SYSMEX CORPORATION希森美康株式会社国食药监械（进）字20028.肺通气功能测定仪(商品名：肺功能仪) (日本福田产业株式会社国食药监械(进)字2007第2400718号29.高密度脂质胆固醇诊断试剂盒 (日本协和医药株式会社国食药监械(进)字2007第2400722号)30.白蛋白检测试剂盒 (西班牙博士泰公司国食药监械(进)字2007第2400723号)31.镁检测试剂盒 (西班牙博士泰公司国食药监械(进)字2007第2400724号)32.葡萄糖检测试剂盒 (西班牙博士泰公司国食药监械(进)字2007第2400725号)33.HL-9000/IONEA型高电位治疗器 (株式会社日本医疗科学国药管械(进)2002第2210693号(更))34.BIO 2001 生殖泌尿系统生物反馈电刺激治疗仪 (METRASOL公司国食药监械(进)字2004第3260453号35.CD3-FITC荧光单克隆抗体试剂 (法国 IMMUNOTECH S.A.S （美国贝克曼库尔特有限公司分公司）国36.CD38-FITC荧光单克隆抗体试剂 (法国 IMMUNOTECH S.A.S （美国贝克曼库尔特有限公司分公司）国37.胰淀粉酶测定试剂盒 (关东化学株式会社国食药监械(进)字2007第2400711号)38.类风湿因子诊断试剂盒 ( 国食药监械(进)字2005第3401715号(更))39.前白蛋白诊断试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第240145140.组织脱水机(商品名：珊顿组织脱水机) (美国 Thermo Electron Corporation 国食药监械(进)字2041.切片机(商品名：珊顿冷冻切片机) (美国 Thermo Electron Corporation 国食药监械(进)字2007第42.组织脱水机(商品名：珊顿全密封组织脱水机) (美国 Thermo Electron Corporation 国食药监械(进43.呼吸球及附件 (VBM Medizintechnik GmbH 国食药监械(进)字2007第1540638号)44.麻醉面罩 (Mallinckrodt Dar S.r.l. 国食药监械(进)字2007第1540643号)45.牙科种植体手术工具 (MegaGen Co.,Ltd. 国食药监械(进)字2007第1550546号)46.酒精诊断试剂盒 (德国罗氏诊断有限公司国食药监械(进)字2007第3400693号)47.转铁蛋白诊断试剂盒 ( 国食药监械(进)字2005第3401771号(更))48.全段甲状旁腺激素试剂盒 ( 国食药监械(进)字2006第3401974号(更))49.全自动荧光磁微粒酶免分析仪 (日本东曹株式会社日本东曹株式会社国食药监械(进)字2007第240050.化学发光分析仪 (德国 DiaSorin Deutschland GmbH 国食药监械(进)字2007第2400559号)51.丙氨酸氨基转移酶试剂盒 (Dade Behring Inc. 国食药监械(进)字2007第2400705号)52.低密度脂质胆固醇诊断试剂盒 (协和医药株式会社国食药监械(进)字2007第2400708号)53.甘油三酯诊断试剂盒 (协和医药株式会社国食药监械(进)字2007第2400709号)54.手术膜 (美国 3M Company3M Company 国食药监械(进)字2007第2640542号)55.高密度/低密度胆固醇校准液 ( 国食药监械(进)字2005第3402329号(更))56.通用稀释液8 ( 国食药监械(进)字2005第3401703号(更))57.植入式心脏起搏器 (美国 Guidant Corporation Cardiac Pacemakers Inc. 国食药监械(进)字200658.通用稀释液1 ( 国食药监械(进)字2005第3401697号(更))59.中空螺钉(商品名：Magana-Fx内固定中空螺钉) (美国 Zimmer Inc. 捷迈公司国食药60.带锁髓内钉(商品名：M/DN) (美国 Zimmer Inc. 捷迈公司国食药监械（进）字2007第3461044号)61.全髋关节系统(商品名：Elite Plus) (英国 DePuy International Ltd 国食药监械（进）字2007第62.内固定线缆系统(商品名：ATLAS) (美国 Medtronic Sofamor Danek USA Inc. 国食药监械（进）字63.髋关节假体(商品名：VerSys推荐型髋关节假体) (美国 Zimmer Inc. 捷迈公司国食药监械（进）字64.鼻塞(商品名：Raucocel 鼻塞) (（Deutschland）Lohmann & Rauscher 国际股份有限公司国食药监65.腹腔镜及附件(商品名：腹腔镜及附件) (奥林巴斯苇音特和意北公司国食药监械(进)字2007第322066.Acculan电池动力系统 (Aesculap AG & Co. KG 国食药监械(进)字2004第2211422号(更))67.透析用碳酸氢钠干粉 (B. Braun Medizintechnologie GmbH 国食药监械(进)字2004第3451444号(更68.二氧化碳校准液/稀释液 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第340269.乙烯基聚硅氧烷咬合检测印模材料(商品名:而至精确咬合记录II型) (日本株式会社而至国食药监械70.用于口腔粘膜的亲水乙烯基聚硅氧烷印模材料(商品名:而至精确义齿记录) (日本株式会社而至国食71.而至快速自凝基托树脂 (株式会社而至国食药监械(进)字2005第3632051号(更))72.而至义齿贴合点指示剂 (而至株式会社国食药监械(进)字2005第2633109号(更))73.胰岛素校准液 ( 国食药监械(进)字2005第3402318号(更))74.通用稀释液10 ( 国食药监械(进)字2005第3401704号(更))75.铜蓝蛋白试剂盒 (英国 THE BINDING SITE公司国食药监械(进)字2007第3400649号)76.补体C4试剂盒 (The Binding Site Limited 国食药监械(进)字2007第3400650号)77.气动动力系统 (Aesculap AG & CO.KG 国食药监械(进)字2005第2541844号(更))78.避孕套 (马来西亚康乐工业有限公司国食药监械(进)字2006第3661816号(更))79.导引导管 (Boston Scientific Corporation 国食药监械(进)字2005第3773129号(更))80.Cardio MD（单光子发射计算机断层）伽玛相机系统 (ADAC Laboratories A Philips Medical Syst81.全自动组织脱水机 (德国徕卡仪器公司Leica Microsystems Nussloch GmbH 国食药监械(进)字200382.耐甲氧西林金黄色葡萄球菌鉴定培养基 (bioMerieux,sa 国食药监械(进)字2006第3400205号(更))83.洗脱缓冲液 (日本 TOSOH CORPORATION 国食药监械（进）字2007第3400983号)84.C反应蛋白校准品 ( 国食药监械（进）字2007第3400985号)85.胆红素定标品 ( 国食药监械（进）字2007第3400986号)86.脂类定标品 (SYSMEX CORPORATION 国食药监械（进）字2007第3400987号)87.质控品 ( 国食药监械（进）字2007第3400988号)88.糖化血清蛋白测定试剂盒（生化酶法） (英国 Genzyme Diagnostic 国食药监械（进）字2007第34089.高频电烧装置 (日本奥林巴斯医疗株式会社 OLYMPUS MEDICAL SYSTEMS CORP. 国食药监械(进)字290.正电子发射及计算机断层扫描系统 (美国 Siemens Medical Solutions USA,Inc 国食药监械(进)字91.荧光探针脱氧核糖核酸检测系统 (美国 Becton,Dickinsonand Company公司国食药监械(进)字200792.促肾上腺皮质激素定标液 (Roche Diagnostics GmbH 国食药监械(进)字2007第3400501号)93.水杨酸盐试剂盒 (Dade Behring, Inc. 国食药监械(进)字2007第3400646号)94.叶酸诊断试剂盒 (德国罗氏诊断有限公司Roche Diagnostics GmbH 国食药监械(进)字2007第3400695.免疫球蛋白M试剂盒 (The Binding Site Limited 国食药监械(进)字2007第3400648号)96.一次性胰岛素注射器带针头 ( 国食药监械(进)字2004第3152002号(更))97.带恒速调节器的输液管路 (Baxter S.A. 国食药监械(进)字2004第3661717号(更))98.百耐凝胶（Bionect gel） (意大利 Fidia制药厂国食药监械(进)字2005第2640099号(更))99.自粘性硅胶片(商品名：仙卡) (Smith & Nephew Medical Ltd. 国食药监械(进)字2007第2660635号100.一次性使用真空采血管 (Greiner Bio-One Gmbh 国食药监械(进)字2007第2660642号)101.喉罩导气管 (塞舌尔 The Laryngeal Mask Company Limited 国食药监械(进)字2007第2660719号) 102.甲状腺过氧化酶自身抗体试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字20 103.通用稀释液7 ( 国食药监械(进)字2005第3401702号(更))104.X射线摄影暗匣(商品名：柯达 X-OMAT 暗盒) (美国 EASTMAN KODAK COMPANYEASTMAN KODAK COMPA 105.电解质参比液 (德国罗氏诊断有限公司国食药监械(进)字2007第1400716号)106.诱导剂 (芬兰 PerkinElmer Life and Analytical Sciences，Wallac Oy 国食药监械(进)字2007第107.甲状腺球蛋白试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第340054108.甲状腺过氧化物酶抗体试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004 109.四碘甲状腺原氨酸试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第34 110.植入式心脏起搏器 (美国 Guidant Corporation Cardiac Pacemakers Inc. 国食药监械(进)字200 111.超声诊断系统和探头 (Philips Ultrasound, INC. 国食药监械(进)字2004第3230502号(更))112.血糖监测仪 (Infopia CO.,Ltd. 国食药监械(进)字2005第2402628号(更))113.血糖试条 (Infopia Co.,Ltd 国食药监械(进)字2005第2402611号(更))114.低温等离子体灭菌器 ( 国食药监械(进)字2005第2571415号(更))115.地高辛试剂盒 ( 国食药监械(进)字2005第3401304号(更))116.万古霉素试剂盒 ( 国食药监械(进)字2005第3401383号(更))117.卡马西平试剂盒 ( 国食药监械(进)字2005第3401379号(更))118.高频电外手科术和电凝设备(商品名：VIO系列高频电外科系统) (德国爱尔博电子医疗仪器公司国119.肺炎链球菌抗生素敏感实验用抗生素 (美国 biomerieux,Inc. 国食药监械(进)字2007第3400685号120.维生素B12试剂盒 ( 国食药监械(进)字2005第3401380号(更)121.白蛋白试剂盒Albumin (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第34001 122.甘油三酯试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400140号( 123.齿科烤瓷合金(商品名：Ceradelta 2) (Metalor Technologies SA 国食药监械(进)字2007第26306124.排龈膏 (法国 Produits Dentaires Pierre Rolland SAS,Acteon Pharma Division 国食药监械(进125.烤瓷瓷粉(商品名：烤瓷瓷粉) (德国 Hager & Werken GmbH & Co.，KG 国食药监械(进)字2007第2 126.医疗压力带(商品名：医疗压力带) (LABORATORI PIAZZA S.r.l. 国食药监械(进)字2007第2640509 127.藻酸钙止血贴 (美国 TZ Medical Inc.TZ Medical Inc. 国食药监械(进)字2007第2640512号) 128.抗核抗体谱(IgG)检测试剂盒(欧蒙印迹法) (德国 EUROIMMUN Medizinische Labordiagnostika AG 129.医用诊断X射线管组件 (美国 Varian Medical Systems 国食药监械(进)字2007第2310622号)130.血糖仪 (韩国 i-SENS.Inc 国食药监械(进)字2007第2400442号)131.尿液分析仪 (盈东电子株式会社国食药监械(进)字2007第2400447号)132.碳13红外光谱仪 (日本大塚电子株式会社国食药监械(进)字2007第2400451号)133.血糖检测系统(商品名：罗康全优越型) (德国罗氏诊断有限公司国食药监械(进)字2007第240045 134.半自动血凝分析仪 (德国　MERLIN medical GmbH 国食药监械(进)字2007第2400476号)135.疝环充填补片(商品名：巴德) (美国 Davol Inc.,Subsidiary of C.R. Bard,Inc. 国食药监械(进 136.疝修补平片和预裁补片(商品名：巴德) (美国 Davol Inc.,Subsidiary of C.R. Bard,Inc. 国食137.切口疝补片(商品名：巴德) (美国 Davol Inc.,Subsidiary of C.R. Bard,Inc. 国食药监械(进)字138.348 Hct Slope 试剂盒 ( 国食药监械(进)字2004第3401406号(更))139.6.838缓冲液 ( 国食药监械(进)字2004第3401410号(更))140.病人固定系统(商品名：UON-DUON) (比利时 ORFIT INDUSTRIES N.V 国食药监械(进)字2007第1100 141.病人固定系统(商品名：EFFICAST) (比利时 ORFIT Industries N.V 国食药监械(进)字2007第1100 142.病人固定系统(商品名：AIO Solution) (比利时 ORFIT INDUSTRIES N.V 国食药监械(进)字2007第143.矫形外科（骨科）手术器械 (奥地利 I.T.S Implantat-Technologie Systeme GmbH 国食药监械(进144.椎间融合器安装工具(商品名：椎间融合器安装工具) (俄罗斯《KIMPF》股份有限公司 Closedjoi 145.组件式短柄假体工具(商品名：Metha) (AESCULAP AG & CO.KG 国食药监械(进)字2007第1100568号146.矫形外科手术器械 (韩国GS医疗公司GS Medical 国食药监械(进)字2007第1100706号)147.医用干式胶片(商品名：富士) (日本 Fuji Photo Film Co.,Ltd 国食药监械(进)字2007第1240484 148.接骨板和接骨螺钉(商品名：LINK 接骨板和接骨螺钉系统) ( 国食药监械（进）字2007第3461012号149.机械心脏瓣膜(商品名：Regent) (美国圣犹达医疗用品有限公司国食药监械（进）字2007第3461 150.血气分析仪 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第2401337号(更)) 151.血气分析仪 (英国 Siemens Medical Solutions Diagnostics Manufacturing Limited 国食药监152.危重症检测分析仪系列 ( 国食药监械(进)字2006第2210279号(更))153.348 Buffer Pack 试剂盒 ( 国食药监械(进)字2004第3401443号(更))154.348/248冲洗液试剂盒 ( 国食药监械(进)字2004第3401531号(更))155.玻璃离子水门汀(商品名：FUJI PLUS) (日本　株式会社而至国食药监械(进)字2006第3631801号(156.乙烯基聚硅氧烷印模材料(膏剂型)(商品名：而至精确硅橡胶膏剂型) (株式会社而至国食药监械157.球囊预装支架传送系统(商品名：TriMaxx 冠状动脉预装支架传送系统) (美国 Abbott Vascular D 158.导丝(商品名：HiWire) (美国库克泌尿外科公司；Cook Urological Incorporated 国食药监械(进159.导引导管(商品名：Launcher) (Medtronic, Inc. 国食药监械(进)字2007第3770627号)160.护套介入系统(商品名：Brite Tip) (Cordis Corporation 国食药监械(进)字2007第3770629号) 161.革兰氏阴性细菌药敏实验用抗生素 (美国 biomerieux,Inc. 国食药监械(进)字2007第3400686号) 162.皮质醇试剂盒 (美国 Bayer HealthCare LLC 国食药监械(进)字2007第3400687号)163.系列冲洗液/废液试剂盒 (美国 Siemens Medical Solutions Diagnostics 国食药监械(进)字2007 164.测量试剂盒 (美国 Siemens Medical Solutions Diagnostics 国食药监械(进)字2007第3400689号165.便潜血测定试剂盒 (日本株式会社常光国食药监械(进)字2007第3400690号)166.肌钙蛋白－I测定试剂盒 (日本株式会社常光国食药监械(进)字2007第3400691号)167.肌红蛋白测定试剂盒 (日本株式会社常光国食药监械(进)字2007第3400692号)168.穆法 MV 呼吸机 (G.LOHMEIER GmbH 国食药监械(进)字2005第3541326号(更))169.全自动蛋白印迹仪 (Genelabs Diagnostics Pte. Ltd. 国食药监械(进)字2005第3402673号(更)) 170.泌尿系统致病菌鉴定培养基 (bioMerieux,sa 国食药监械(进)字2005第3403472号(更))171.庆大霉素试剂盒 ( 国食药监械(进)字2005第3401378号(更))172.髋部螺钉系统(商品名：亚洲型) (美国 Smith & Nephew, Inc. Orthopaedic Division 国食药监械173.肌酸激酶MB同工酶校准液 ( 国食药监械(进)字2005第3401797号(更))174.移动式X射线诊断设备 (Siemens AG 国食药监械(进)字2007第2300704号)175.影像板扫描处理系统(商品名：柯达 Point-of-Care CR 系统) (美国 Eastman Kodak Company 国食176.X射线口内影像系统 (韩国 VATECH Co.Ltd. 国食药监械(进)字2007第2310517号)177.血液透析用管道Lines for hemodialysis (Gambro DASCO S.p.A 国食药监械（进）字2007第34507 178.管路及滤器H.E.L.P. Consumables (德国 B.Braun Medizintechnologie GmbH 国食药监械（进）字179.血浆分离器(商品名：Haemoselect) (德国 B. Braun Medizintechnologie GmbH 国食药监械（进）180.补体C3诊断试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第3401775号181.可吸收骨替代材料（商品名：固骼生） (美国诺邦生物制品有限公司国食药监械(进)字2004第346 182.尿分析阳性和阴性质控试纸 ( 国食药监械(进)字2006第3401062号(更))183.尿液分析仪 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第2401280号(更)) 184.尿液分析仪 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第2402147号(更)) 185.校准液C ( 国食药监械(进)字2005第3401788号(更))186.校准液B ( 国食药监械(进)字2005第3401800号(更))187.校准液A ( 国食药监械(进)字2005第3401787号(更))188.C反应蛋白（Ⅱ）乳胶试剂盒X2 (日本 DENKA SEIKEN CO., LTD. 国食药监械(进)字2006第3400929 189.D-二聚体排除试验试剂盒 (bioMerieux,sa 国食药监械(进)字2005第3401130号(更))190.多功能医疗护理床系列 (捷克共和国Linet spol.sr.o. 国食药监械(进)字2004第2542365号(更)) 191.Multifiltrate Cassette 管路系统 (德国 Fresenius Medical Care AG & Co.KGaA 国食药监械(进192.透析液过滤器 (Fresenius Medical Care AG & Co.KGaA 国食药监械(进)字2005第3453077号(更)) 193.穿刺针 (Fresenius Medical Care AG & Co.KGaA 国食药监械(进)字2004第3150589号(更))194.游离三碘甲状腺原氨酸试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004 195.游离甲状腺素试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第340060 196.超声诊断系统 (意大利 ESAOTE SpAESAOTE SpA 国食药监械(进)字2007第3230621号)197.MicroPlex 弹簧圈系统 (MicroVention,Inc 国食药监械(进)字2005第3770791号(更))198.运动负荷试验诊断系统 (Philips Medical Systems 国食药监械(进)字2005第2212430号(更)) 199.动态心电图系统 (Philips Medical Systems 国药管械(进)字2003第2210893号(更))200.心电图机 ( 国食药监械(进)字2004第2210828号(更))201.监护除颤器 (Philips Medical System 国食药监械(进)字2004第3211207号(更))202.正电子发射断层成像系统 (Philips Medical Systems (Cleveland),Inc. 国食药监械(进)字2003第203.免疫球蛋白G诊断试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第340204.Rapidpoint Coag 快速凝血仪PT-NC测试卡 (Siemens Medical Solutions Diagnostics 国食药监械205.髋关节假体(商品名：SDC and PLC) (德国 AESCULAP AG & Co.KGGermany AESCULAP AG & Co.KG 国206.膝关节系统(商品名：AGC DA) (英国 Biomet UK LTD.Biomet UK LTD. 国食药监械(进)字2007第34 207.疝修补网织片(商品名：巴德 Modified Kugel) ( 国食药监械(进)字2007第3460593号)208.角膜接触镜(商品名：强生彩镜) (美国 VISTAKON Johnson&Johnson Vision Care Inc. 国食药监械209.角膜接触镜(商品名：西武) (G&G CONTACT LENS CO. 国食药监械(进)字2007第3220572号)210.超声诊断仪 (GE Medical Systems Kretztechnik GmbH&Co.,OHG 国食药监械(进)字2007第3230494 211.超声诊断系统(商品名：SONOLINE G60 S) (美国 SIEMENS MEDICAL SOLUTIONS USA, INC. 国食药监212.Rapidpoint Coag 快速凝血aPTT测试卡 (Siemens Medical Solutions Diagnostics 国食药监械(进213.银粉玻璃离子水门汀(商品名：而至 Miracle Mix) (日本株式会社而至国食药监械(进)字2007第3 214.氟化泡沫(商品名：氟化泡沫) (美国 Laclede, A Laclede, Inc. 国食药监械(进)字2007第215.去白细胞滤器 (Fresenius Kabi AG 国食药监械(进)字2006第3660078号(更))216.硬膜下电极 (AD-Tech Medical Instrument Corporation 国食药监械(进)字2005第3210648号(更) 217.一次性使用去白细胞滤器 ( 国食药监械（进）字2007第3451019号)218.股骨头及内称(商品名：股骨头及内称) (法国 GROUPE LEPINE 国食药监械（进）字2007第3460914 219.补体C4诊断试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第3401774号220.生化校准液 ( 国食药监械(进)字2006第3400191号(更))221.口腔科手术器械 (德国 Alfred Becht GmbHGermany Alfred Becht GmbH 国食药监械(进)字2007第222.泌尿肛肠外科手术器械 (德国 Aesculap AG & Co.KG 国食药监械(进)字2007第1090477号)223.游离四碘甲状腺原氨酸试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004 224.维生素B12稀释液 ( 国食药监械(进)字2005第3401705号(更))225.B型心钠素校准液 ( 国食药监械(进)字2005第3401785号(更))226.体外循环用插管--心室插管 (Maquet Cardioplumonary AG 国食药监械(进)字2004第3450692号(更227.体外循环用插管--静脉插管 (Maquet Cardioplumonary AG 国食药监械(进)字2004第3450694号(更228.脊椎动力平衡治疗系统 (Optima Health Solutions International Corporation 国食药监械(进) 229.手术室包 (Buckley Lamb Limited 国食药监械(进)字2005第2641933号(更))230.超声成像诊断仪 (Esaote Europe B.V. 国食药监械(进)字2006第3210425号(更))231.免疫球蛋白M诊断试剂盒 ( 国食药监械(进)字2005第3401709号(更))232.妥布霉素试剂盒 ( 国食药监械(进)字2005第3401695号(更))233.苯巴比妥试剂盒 ( 国食药监械(进)字2005第3401693号(更))234.氨测定试剂盒 (日本关东化学株式会社国食药监械(进)字2007第3400674号)235.肌红蛋白测定试剂盒 (日本关东化学株式会社国食药监械(进)字2007第3400675号)236.胃蛋白酶原Ⅰ测定试剂盒 (关东化学株式会社国食药监械(进)字2007第3400676号)237.全瓷(商品名：维他全瓷系列) (德国维他公司 VITA Zahnfabrik H.Rauter Gmbh & Co.KG 国食药238.齿科用铸造合金 (商品名：Solaro 3 ) (瑞士 Metalor Technologies SAMetalor Technologies S 239.齿科烤瓷合金(商品名：V-Gnathos plus ) ( 国食药监械(进)字2007第2630623号)240.齿科烤瓷合金(商品名：V-Deltaloy) (Metalor Technologies SA 国食药监械(进)字2007第263062 241.可吸收外科缝线(商品名：万福（Monosyn）) (德国 AESCULAP AG & CO.KG 国食药监械(进)字2007 242.静脉插管 (美国 Edwards Lifesciences LLC 国食药监械(进)字2007第3660520号)243.肾造瘘扩张器及套装(商品名：Amplatz) (Cook Urological Incorporated 国食药监械(进)字2007 244.连通板英文名称： Merit Manifolds(商品名：麦瑞连通板) (美国麦瑞医疗设备有限公司麦瑞医疗245.铁蛋白试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400273号(更246.高密度脂蛋白测定试剂盒 (日本关东化学株式会社国食药监械(进)字2007第3400673号)247.图像处理装置 (日本オリンパスメディカルシステムズ株式会社国食药监械(进)字2007第222044 248.内窥镜摄像系统 (Karl Storz GmbH & Co.KG 国食药监械(进)字2007第2220473号)249.接触式压电眼压计(商品名：动态轮廓眼压计) (SMT Swiss Microtechnology AG 国食药监械(进)字250.内窥镜下无源手术器械(商品名：蛇牌) (Aesculap AG&Co.KG 国食药监械(进)字2007第2220528号) 251.内窥镜摄像系统 (德国 Karl Storz GmbH & Co.KG 国食药监械(进)字2007第2220554号)252.医学影像存储和传输系统(商品名：医学影像存储和传输系统) (德国 Siemens AGSiemens AG 国食253.内窥镜冷光源 (德国 Richard Wolf GmbH 国食药监械(进)字2007第2220633号)254.牛心包生物瓣(商品名：SJM Biocor) (圣犹达医疗用品公司国食药监械(进)字2007第3460701号) 255.呼吸机(商品名：纽邦呼吸机) (美国 Newport Medical Instruments,Inc.U.S.A.Newport Medical 256.ADVIA 70 血液分析仪 (Siemens Medical Solutions Diagnostics 国药管械(进)2003第2400740号257.ADVIA 血液分析仪 (Siemens Medical Solutions Diagnostics 国药管械(进)2003第2400657号(更258.Kodak Min-R EV乳房X线影像胶片 (Carestream Health,Inc 国食药监械(进)字2004第1310201号(更259.Kodak DVM胶片 ( 国食药监械(进)字2005第1311759号(更))260.超声诊断设备(商品名：超声诊断设备Aplio) (日本 TOSHIBA MEDICAL SYSTEMS CORPORATION 国食261.层析柱 (TOSOH CORPORATION 国食药监械(进)字2007第3460551号)262.自动体外除颤仪 (Medtronic Emergency Response Systems,Inc. 国药管械(进)2002第3211124号( 263.电动动力系统 ( 国食药监械(进)字2005第2211873号(更))264.显微外科手术器械 (德国 Aesculap AG & Co.KGAesculap AG & Co.KG 国食药监械(进)字2007第10 265.根管扩大器 (日本　Mani, Inc. 国食药监械(进)字2007第2550455号)266.喷粉洁牙手机(商品名：PROPHY-MATE) (日本株式会社中西/Nakanishi Inc. 国食药监械(进)字20 267.脉动预真空压力蒸汽灭菌器 (Tuttnauer Co.Ltd. 国食药监械(进)字2007第2570703号)268.牙科复合树脂充填材料(商品名：SwissTec Composite) (Coltene/Whaledent AG 国食药监械(进)字269.ADVIA 70 鞘液 ( 国食药监械(进)字2003第3400427号(更))270.ADVIA 70 稀释液 ( 国食药监械(进)字2003第3400428号(更))271.ADVIA 70 溶血剂 ( 国食药监械(进)字2003第3400429号(更))272.ADVIA 60 TIMEPAC ( 国食药监械(进)字2005第2400926号(更))273.ADVIA 60 血液分析仪 ( 国食药监械(进)字2005第2401875号(更))274.万古霉素校准液 ( 国食药监械(进)字2005第3401795号(更))275.庆大霉素校准液 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第3401794号( 276.远程心电事件记录器 (德国 TMS Telemedizinische Systeme GmbH 国食药监械(进)字2007第22105 277.生物显微镜 (德国 Carl Zeiss AG，Werk Gottingen 国食药监械(进)字2007第2220441号)278.深部电极 (Ad-Tech Medical Instrument Corporation 国食药监械(进)字2005第3210459号(更)) 279.硬膜外麻醉导管 (美国 ARROW INTERNATIONAL INC 国食药监械(进)字2007第3660588号)280.膜型血浆分离器 (日本旭化成医疗株式会社国食药监械(进)字2007第3660590号)281.血栓抽吸导管(商品名：Rebirth ) (日本株式会社Goodman 国食药监械(进)字2007第3660607号) 282.一次性使用输液器用输液帽、防回流阀 (德国 Fresenius Kabi AGFresenius Kabi AG 国食药监械283.Rapidpoint Coag 快速凝血仪 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2003284.胃蛋白酶原Ⅱ测定试剂盒 (日本关东化学株式会社国食药监械(进)字2007第3400677号)285.血脂正常值质控 (德国罗氏诊断有限公司国食药监械(进)字2007第3400678号)286.血脂病理值质控 (德国罗氏诊断有限公司国食药监械(进)字2007第3400679号)287.免疫球蛋白G2试剂 (德国 Dade Behring Marburg GmbH 国食药监械(进)字2007第3400680号)288.免疫球蛋白G1试剂 (德国 Dade Behring Marburg GmbH 国食药监械(进)字2007第3400681号)289.铁蛋白检测试剂盒 (西班牙博士泰公司国食药监械(进)字2007第3400682号)290.脑脊液/尿液总蛋白检测试剂盒 (西班牙博士泰公司国食药监械(进)字2007第3400683号)291.HydroCoil栓塞系统 (MicroVention,Inc 国食药监械(进)字2005第3770789号(更))292.泵用输液器英文名称：Original Infusomat Tubing(商品名：Original Infusomat) (B. Brau 293.麻醉系统(商品名：Zeus) ( 国食药监械(进)字2007第3540615号)294.呼吸加湿过滤系统 (马来西亚 Rusch Sdn Bhd. 国食药监械(进)字2007第3540736号)295.光固化玻璃离子水门汀(商品名：而至富士 II LC ) (日本株式会社而至国食药监械(进)字2007第296.C-肽试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400619号(更)) 297.胰岛素试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400287号(更298.胰岛素试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2004第3400637号(更299.校准液O ( 国食药监械(进)字2005第3401792号(更))300.茶碱试剂盒 ( 国食药监械(进)字2005第3401694号(更))301.动力系统(商品名：Colibri ) (瑞士 Synthes GmbH 国食药监械(进)字2007第2540714号)302.免疫球蛋白A诊断试剂盒 ( 国食药监械(进)字2005第3401710号(更))303.KODAK DirectView CR950 系统 (Carestream Health,Inc 国食药监械(进)字2003第2310504号(更) 304.通用稀释液3 ( 国食药监械(进)字2005第3401699号(更))305.校准液Z ( 国食药监械(进)字2005第3401786号(更))306.校准液E ( 国食药监械(进)字2005第3401799号(更))307.肌酸激酶MB同工酶液体试剂盒 (DiaSys Diagnostic Systems GmbH 国食药监械(进)字2005第24031 308.自体血连续回输机 (Fresenius Kabi AG 国食药监械(进)字2005第3452722号(更))309.S5L/C5L 血小板套件 (Fresenius Kabi AG 国食药监械(进)字2006第3450453号(更))310.PL1血浆置换组件 (Fresenius Kabi AG 国食药监械(进)字2006第3450452号(更))311.血细胞分离机 (Fresenius Kabi AG 国食药监械(进)字2005第3453128号(更))312.CATS自体血回输机耗材 (Fresenius Kabi AG 国食药监械(进)字2006第3450451号(更))313.去白细胞滤器 (Fresenius Kabi AG 国食药监械(进)字2005第3453185号(更))314.通用稀释液4 ( 国食药监械(进)字2005第3401700号(更))315.C反应蛋白诊断试剂盒 (Siemens Medical Solutions Diagnostics 国食药监械(进)字2005第34017316.腹腔镜用缝合材料及辅助器械 (Ethicon Endo-Surgery, Inc. 国食药监械(进)字20317.一次性使用冲洗装置(商品名：CritiFlo) (新加坡　Becton Dickinson Critical Care Systems P 318.一次性使用电刀笔 (TELEFLEX MEDICAL 国食药监械(进)字2005第2252933号(更))319.导电性粘合电极板 (TELEFLEX MEDICAL 国食药监械(进)字2005第2252946号(更))320.R-Stent Evolution 2 冠状动脉支架系统 (美国 Orbus Neich Medical,Inc. 国食药监械(进)字20 321.程控仪(商品名：ZOOMLATITUDE) (美国　Guidant Corporation Cardiac Pacemakers Inc. 国食药322.植入式心脏除颤电极导管 ( 国食药监械(进)字2006第3211955号(更))323.二氧化碳(CO2)液体试剂盒 ( 国食药监械(进)字2004第3400627号(更))324.铁蛋白测定试剂 ( 国食药监械(进)字2004第3400628号(更))325.超声治疗仪(商品名：骨科超声治疗仪) (赛特力公司国食药监械(进)字2007第2230109号)326.中频电疗仪(商品名：Superkine SK-SERIES) ( 国食药监械(进)字2007第2260157号)327.影像板扫描处理系统(商品名：柯达 CR 7400 牙科计算机放射成像系统) (美国　Eastman Kodak C 328.凝血酶原时间测定试剂盒 ( 国食药监械(进)字2007第2400118号)329.凝血酶原时间测定试剂盒 ( 国食药监械(进)字2007第2400119号)330.谷氨酰转肽酶测定试剂盒 (和光纯药工业株式会社国食药监械(进)字2007第2400121号)331.PTA 导管（Amphirion DEEP） (意大利 Invatec S.r.l. 国食药监械(进)字2006第2771389号)。

3种含铋剂四联方案根除幽门螺杆菌的临床疗效研究

3种含铋剂四联方案根除幽门螺杆菌的临床疗效研究潘萍，杨芸，张立江苏大学附属武进医院药学部，江苏常州213002[摘要]目的比较3种含铋剂四联疗法治疗幽门螺杆菌的临床治疗效果，为选择理想的初次根治方案提供依据。

方法回顾性分析2022年1—9月江苏大学附属武进医院收治的96例幽门螺杆菌阳性患者的临床资料，根据不同治疗方案分为3组，A组（35例）：阿莫西林胶囊+克拉霉素缓释片+雷贝拉唑肠溶胶囊+枸橼酸铋钾胶囊；B组（32例）：阿莫西林胶囊+左氧氟沙星片+雷贝拉唑肠溶胶囊+枸橼酸铋钾胶囊；C组（29例）：克拉霉素缓释片+左氧氟沙星片+雷贝拉唑肠溶胶囊+枸橼酸铋钾胶囊。

比较各组方案的临床疗效和不良反应。

结果A、B、C 组幽门螺杆菌根除率分别为85.71%、81.25%、75.86%，差异无统计学意义（χ2= 1.010，P=0.609）。

3组方案药物不良反应发生率分别为5.71%、6.25%、10.34%，差异无统计学意义（χ2=0.694，P=0.789）。

结论阿莫西林联合克拉霉素方案Hp根除率相对较高、安全性较好，可作为初次根治治疗的首选方案；克拉霉素联合左氧氟沙星方案Hp根除率低，不宜选用。

[关键词]幽门螺杆菌；四联疗法；铋剂；疗效[中图分类号]R4 [文献标识码]A [文章编号]2096-1782（2023）09(b)-0183-04Clinical Efficacy Study of Three Bismuth-containing Quadruple Regimens for the Eradication of Helicobacter pyloriPAN Ping, YANG Yun, ZHANG LiDepartment of Pharmacy, Wujin Hospital Affiliated to Jiangsu University, Changzhou, Jiangsu Province, 213002 China [Abstract] Objective To compare the clinical therapeutic effects of three bismuth-containing quadruple regimens for the treatment of Helicobacter pylori, and to provide a basis for selecting an ideal initial eradication program. Methods The clinical data of 96 Helicobacter pylori positive patients admitted to Wujin Hospital Affiliated to Jiangsu Univer⁃sity from January to September 2022 were retrospectively analyzed and divided into 3 groups according to different treatment plans. Group A (35 cases): Amoxicillin capsule+clarithromycin sustained-release tablet+rabeprazole enteric-coated capsule+bismuth potassium citrate capsule; Group B (32 cases): amoxicillin capsule+Levofloxacin tab⁃let+Rabeprazole enteric-coated capsule+bismuth potassium citrate capsule; Group C (29 cases):clarithromycin sustained-release tablet+levofloxacin tablet+rabeprazole enteric capsule+bismuth potassium citrate capsule. The clini⁃cal efficacy and adverse reactions of each group were compared. Results The eradication rates of H. pylori in groups A, B and C were 85.71%, 81.25% and 75.86%, respectively, and the difference was not statistically significant (χ2= 1.010, P=0.609). The incidence of adverse drug reactions in the three groups was 5.71%, 6.25% and 10.34%, respec⁃tively, and the difference was not statistically significant (χ2=0.694, P=0.789). Conclusion Amoxicillin combined with clarithromycin has higher eradication rate and good safety of Hp, which can be used as the first choice of radical treat⁃ment. Clarithromycin combined with levofloxacin has a low eradication rate of Hp and should not be used.[Key words] Helicobacter pylori; Quadruple therapy; Bismuth; Efficacy幽门螺杆菌（helicobacter pylori, Hp）是一种螺旋状的革兰氏阴性菌，进入人体后可寄生在口腔、胃和十二指肠等部位[1]。

Incucyte

Product Information Presentation, Storage and StabilityThe Incucyte® Fabfluor-pH Antibody Labeling Reagents for antibody internalization are supplied as lyophilized solids in sufficient quantity to label 50 μg of test antibody, when used at the suggested molar ratio (1:3 of test antibody to labeling Fab). The lyophilized solid can be stored at 2-8° C for one year. Once re-hydrated, any unused reagent should be aliquoted and stored at -80° C for up to one year. Avoid repeated freeze-thaw cycles.Incucyte® Fabfluor-pH Antibody Labeling ReagentsFor Antibody Internalization AssaysAntibody Labeling Reagent Rehydrated: -80° C *Excitation and Emission maxima were determined at a pH of 4.5.Fabfluor_quick_guideBackgroundIncucyte ® Fabfluor-pH Antibody Labeling Reagents are designed for quick, easy labeling of Fc-containing test antibodies with a Fab fragment-conjugated pH-sensitive fluorophore. The pH-sensitive dye based system exploits the acidic environment of the lysosomes to quantify in-ternalization of the labeled antibody. As Fabfluor labeled antibodies reside in the neutral extracellular solution (pH 7.4), they interact with cell surface specific antigens and are internalized. Once in the lysosomes, they enter an acidic environment (pH 4.5–5.5) and a substantial in-crease in fluorescence is observed. In the absence of ex-pression of the specific antigen, no internalization occurs and the fluorescence intensity of the labeled antibodies remains low. With the Incucyte ® integrated analysis soft-ware, background fluorescence is minimized. These reagents have been validated for use with a number of different antibodies in a range of cell types. The Incucyte ® Live-Cell Analysis System enables real-time, kinetic eval -uation of antibody internalization.Recommended UseWe recommend that the Incucyte ® Fabfluor-pH Antibody Labeling Reagents are prepared at a stock concentration of 0.5 mg/mL by the addition of 100 μL of sterile water and triturated (centrifuge if solution not clear). The reagent may then be diluted directly into the labeling mixture with test antibody. Do NOT sonicate the solution.Additional InformationThe Fab antibody was purified from antisera by a combination of papain digestion and immunoaffinity chromatography using antigens coupled to agarose beads. Fc fragments and whole IgG molecules have been removed.Human Red (Cat. No. 4722) or Human Orange (Cat. No. 4812)—Based on immunoelectrophoresis and/ or ELISA, the antibody reacts with the Fc portion of human IgG heavy chain but not the Fab portion of human IgG. No antibody was detected against human IgM, IgA or against non-immunoglobulin serum proteins. The anti-body may cross-react with other immunoglobulins from other species.Mouse IgG1 (Cat. No. 4723), IgG2a (Cat. No. 4750) or IgG2b (Cat. No. 4751)—Based on antigen-binding assay and/or ELISA, the antibody reacts with the Fc portion of mouse IgG, IgG2a or IgG2b, respectively, but not the Fab portion of mouse immunoglobulins. No antibody was detected against mouse IgM or against non–immunoglobulin serum proteins. The antibody may cross-react with other mouse IgG subclasses or with immunoglobulins from other species.Rat (Cat. No. 4737)—Based on immunoelectrophoresis and/or ELISA, the antibody reacts with the Fc portion of rat IgG heavy chain but not the Fab portion of rat IgG. No antibody was detected against rat IgM, IgA or against non-immunoglobulin serum proteins. The antibody may cross-react with other immunoglobulins from other species.A.B.C.D.R e d O b j e c t A r e a (x 105 μm 2 p e r w e l l )Time (hours)A U C x 106 (0–12 h )log [α–CD71] (g/mL)Example DataFigure 1: Concentration-dependent increase in antibody internalization of Incucyte ® Fabfluor labeled-α-CD71 in HT1080 cells. α-CD71 and mouse IgG1 isotype control were labeled with Incucyte ® Mouse IgG1 Fabfluor-pH Red Antibody Labeling Reagent. HT1080 cells were treated with either Fabfluor-α-CD71 or Fabfluor-IgG1 (4 μg/mL); HD phase and red fluorescence images were captured every 30 minutes over 12 hours using a 10X magnification. (A) Images of cells treated with Fabfluor-α-CD71 display red fluorescence in the cytoplasm (images shown at 6 h). (B) Cells treated with labeled isotype control display no cellular fluorescence. (C) Time-course of Fabfluor-α-CD71 internalization with increasing concentrations of Fabfluor-α-CD71 (progressively darker symbols). Internalization has been quantified as the red object area for each time-point. (D) Concentration response curve to Fabfluor-α-CD71. Area under the curve (AUC) values have been determined from the time-course shown in panel C (0-12 hours) and are presented as the mean ± SEM, n=3 wells.CD71-FabfluorIgG-FabfluorProtocols and ProceduresMaterialsIncucyte® Fabfluor-pH Antibody Labeling ReagentTest antibody of interest containing human, mouse, or rat IgG Fc region (at known concentration)Target cells of interestTarget cell growth mediaSterile distilled water96-well flat bottom microplate (e.g. Corning Cat. No. 3595) for imaging96-well round black round bottom ULA plate (e.g. Corning Cat. No. 45913799) or amber microtube (e.g. Cole Parmer Cat. No. MCT-150-X, autoclaved) for conjugation step0.01% Poly-L-Ornithine (PLO) solution (e.g. Sigma Cat. No. P4957), optional for non-adherent cells Recommended control antibodiesIt is strongly recommended that a positive and negative control is run alongside test antibodies and cell lines. For example, CD71, which is a mouse anti-human antibody, is recommended as a positive control for the mouse Fab.Anti-CD71, clone MEM-189, IgG1 e.g. Sigma Cat. No. SAB4700520-100UGAnti-CD71, clone CYG4, IgG2a e.g. BioLegend Cat. No. 334102Isotype controls, depending on isotype being studied—Mouse IgG1, e.g. BioLegend Cat. No. 400124, Mouse IgG2a e.g. BioLegend Cat. No. 401501Preparation of Incucyte® Antibody Internalization Assay 1. Seed target cells of interest1.1 Harvest cells of interest and determine cell concentra-tion (e.g. trypan blue + hemocytometer).1.2 Prepare cell seeding stock in target cell growth mediawith a cell density to achieve 40–50% confluence be-fore the addition of labeled antibodies. The suggested starting range is 5,000–30,000 cells/well, although the seeding density will need to be optimized for each cell type.Note: For non-adherent cell types, a well coating may be required to maintain even cell distribution in the well. For a 96-well flat bottom plate, we recommend coating with 50 μL of either 0.01% Poly-L-Or-nithine (PLO) solution or 5 μg/mL fibronectin diluted in 0.1% BSA.Coat plates for 1 hour at ambient temperature, remove solution from wells and then allow the plates to dry for 30-60 minutes prior to cell addition.1.3 Using a multi-channel pipette, seed cells (50 µL perwell) into a 96-well flat bottom microplate. Lightly tapplate side to ensure even liquid distribution in well. Toensure uniform distribution of cells in each well, allowthe covered plate sit on a level surface undisturbed at room temperature in the tissue culture hood for 30minutes. After cells are settled, place the plate insidethe Incucyte® Live-Cell Analysis System to monitor cell confluence.Note: Depending on cell type, plates can be used in assay once cells have adhered to plastic and achieved normal cell morphology e.g.2-3 hours for HT1080 or 1-2 hours for non-adherent cell types. Some cell types may require overnight incubation.2. Label Test Antibody2.1 Rehydrate the Incucyte® Fabfluor-pH Antibody Label-ing Reagent with 100 µL sterile water to result in a final concentration of 0.5 mg/mL. Triturate to mix (centrifuge if solution is not clear).Note: The reagent is light sensitive and should be protected fromlight. Rehydrated reagent can be aliquoted into amber or foilwrapped tubes and stored at -80° C for up to 1 year (avoid freezing and thawing).2.2 Mix test antibody with rehydrated Incucyte® Fabfluor–pH Antibody Labeling Reagent and target cell growth media in a black round bottom microplate or ambertube to protect from light (50 µL/well).a. Add test antibody and Incucyte® Fabfluor–pH Anti-body Labeling Reagent at 2X the final concentration.We suggest optimizing the assay by starting with afinal concentration of 4 µg/mL of test antibody or theFabfluor-pH Antibody Labeling Reagent (i.e. 2Xworking concentration = 8 µg/mL).Note: A 1:3 molar ratio of test antibody to Incucyte® Fabfluor-pHAntibody Labeling Reagent is recommended. The labeling re-agent is a third of the size of a standard antibody (50 and 150KDa, respectively). Therefore, labeling equal quantities will pro-duce a 1:3 molar ratio of test antibody to labeling Fab.b. Make sufficient volume of 2X labeling solution for50 µL/well for each sample. Triturate to mix.c. Incubate at 37° C for 15 minutes protected from light.Note: If performing a range of concentrations of test antibody,e.g. concentration response-curve, it is recommended to createthe dilution series post the conjugation step to ensure consistentmolar ratio. We strongly recommend the use of both a negativeand positive control antibody in the same plate.3. Add labeled antibody to cells3.1 Remove cell plate from incubator.3.2 Using a multi-channel pipette, add 50 µL of 2X labeledantibody and control solutions to designated wells.Remove any bubbles and immediately place plate in the Incucyte® Live-Cell Analysis System and start scanning.Note: To reduce the risk of condensation formation on the lid priorto first image acquisition, maintain all reagents at 37° C prior toplate addition.4. Acquire images and analyze4.1 In the Incucyte® Software, schedule to image every15-30 minutes, depending on the speed of the specific antibody internalization.a Scan on schedule, standard. If the Incucyte® Cell-by-Cell Analysis Software Module (Cat. No. 9600-0031)is available, adherent cell-by-cell or non-adherentcell-by-cell scan types can be selected.b Channel selection: select “phase” and “red” or“phase” and "orange” (depending on reagent used).c Objective: 10X or 20X depending on cell types used,generally 10X is recommended for adherent cells,and 20X for non-adherent or smaller cells.NOTE: The optional Incucyte® Cell-by-Cell Analysis SoftwareModule enables the classification of cells into sub-populationsbased on properties including fluorescence intensity, size andshape. For further details on this analysis module and its appli-cation, please see: /cell-by-cell.4.2 To generate the metrics, user must create an AnalysisDefinition suited to the cell type, assay conditions andmagnification selected.4.3 Select images from a well containing a positiveinternalization signal and an isotype control well(negative signal) at a time point where internalizationis visible.4.4 In the Analysis Definition:Basic Analyzer:a. Set up the mask for the phase confluence measurewith fluorescence channel turned off.b. Once the phase mask is determined, turn the fluores-cence channel on: Exclude background fluorescencefrom the mask using the background subtractionfeature. The feature “Top-Hat” will subtract localbackground from brightly fluorescent objects withina given radius; this is a useful tool for analyzing ob-jects which change in fluorescence intensity overtime.i The radius chosen should reflect the size of thefluorescent object but contain enough backgroundto reliably estimate background fluorescence inthe image; 20-30 μm is often a useful startingpoint.ii The threshold chosen will ensure that objectsbelow a fluorescence threshold will not bemasked.iii Choose a threshold in which red or orange objectsare masked in the positive response image but lownumbers in the isotype control, negative responsewell. For a very sensitive measurement, for example,if interested in early responses, we suggest athreshold of 0.2.NOTE: The Adaptive feature can be used for analysis but maynot be as sensitive and may miss early responses. If interestedin rate of response, Top-Hat may be preferable.Cell-by-Cell (if available):a. Create a Cell-by-Cell mask following the softwaremanual.b. There is no need to separate phase and fluorescencemasks. The default setting of Top-Hat No Mask forthe fluorescence channel will enable backgroundsubtraction without generation of a mask. Ensurethat the Top-Hat radius is set to a value higher thanthe radius of the larger clusters to avoid excess back-ground subtraction.c. The threshold of fluorescence can be determined inCell-by-Cell Classification.Specifications subject to change without notice.© 2020. All rights reserved. Incucyte, Essen BioScience, and all names of Essen BioScience prod -ucts are registered trademarks and the property of Essen BioScience unless otherwise specified. Essen BioScience is a Sartorius Company. Publication No.: 8000-0728-A00Version 1 | 2020 | 04Sales and Service ContactsFor further contacts, visit Essen BioScience, A Sartorius Company /incucyte Sartorius Lab Instruments GmbH & Co. KGOtto-Brenner-Strasse 20 37079 Goettingen, Germany Phone +49 551 308 0North AmericaEssen BioScience Inc. 300 West Morgan Road Ann Arbor, Michigan, 48108USATelephone +1 734 769 1600E-Mail:***************************EuropeEssen BioScience Ltd.Units 2 & 3 The Quadrant Newark CloseRoyston Hertfordshire SG8 5HLUnited KingdomTelephone +44 (0) 1763 227400E-Mail:***************************APACEssen BioScience K.K.4th floor Daiwa Shinagawa North Bldg.1-8-11 Kita-Shinagawa Shinagawa-ku, Tokyo 140-0001 JapanTelephone: +81 3 6478 5202E-Mail:*************************5. Analysis GuidelinesAs the labeled antibody is internalized into the acidic environment of the lysosome, the area of fluorescence intensity inside the cells increases.This can be reported in two ways:Ways to Report Basic AnalyzerCell-by-Cell Analysis* To correct for cell proliferation, it is advisable to normalize the fluorescence area to the total cell area using User Defined Metrics.For Research Use Only. Not For Therapeutic or Diagnostic Use.LicensesFor non-commercial research use only. Not for therapeutic or in vivo applications. Other license needs contact Essen BioS cience.Fabfluor-pH Red Antibody Labeling Reagent: This product or portions thereof is manufactured under license from Carnegie Mellon University and U.S. patent numbers 7615646 and 8044203 and related patents. This product is licensed for sale only for research. It is not licensed for any other use. There is no implied license hereunder for any commercial use.Fabfluor-pH Orange Antibody Labeling Reagent: This product or portions thereof is manufactured under a license from Tokyo University and is covered by issued patents EP2098529B1, JP5636080B2, US8258171, and US9784732 and related patent applications. This product and related products are trademarks of Goryo Chemical. Any application of above mentioned technology for commercial purpose requires a separate li -cense from: Goryo Chemical, EAREE Bldg., SF Kita 8 Nishi 18-35-100, Chuo-Ku, Sapporo, 060-0008 Japan.SupportA complete suite of cell health applications is available to fit your experimental needs. Find more information at /incucyte Foradditionalproductortechnicalinformation,************************************************************/incucyte。

AZD7545_SDS_MedChemExpress

Inhibitors, Agonists, Screening LibrariesSafety Data Sheet Revision Date:May-24-2017Print Date:May-24-20171. PRODUCT AND COMPANY IDENTIFICATION1.1 Product identifierProduct name :AZD7545Catalog No. :HY-16082CAS No. :252017-04-21.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses :Laboratory chemicals, manufacture of substances.1.3 Details of the supplier of the safety data sheetCompany:MedChemExpress USATel:609-228-6898Fax:609-228-5909E-mail:sales@1.4 Emergency telephone numberEmergency Phone #:609-228-68982. HAZARDS IDENTIFICATION2.1 Classification of the substance or mixtureGHS Classification in accordance with 29 CFR 1910 (OSHA HCS)Acute toxicity, Oral (Category 4),H302Acute aquatic toxicity (Category 1),H400Chronic aquatic toxicity (Category 1),H4102.2 GHS Label elements, including precautionary statementsPictogramSignal word WarningHazard statement(s)H302 Harmful if swallowed.H410 Very toxic to aquatic life with long lasting effects.Precautionary statement(s)P264 Wash skin thoroughly after handling.P270 Do not eat, drink or smoke when using this product.P273 Avoid release to the environment.P301 + P312 IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.P330 Rinse mouth.P391 Collect spillage.P501 Dispose of contents/ container to an approved waste disposal plant.2.3 Other hazardsNone.3. COMPOSITION/INFORMATION ON INGREDIENTS3.1 SubstancesSynonyms:AZD 7545; AZD⁻7545Formula:C19H18ClF3N2O5SMolecular Weight:478.87CAS No. :252017-04-24. FIRST AID MEASURES4.1 Description of first aid measuresEye contactRemove any contact lenses, locate eye-wash station, and flush eyes immediately with large amounts of water. Separate eyelids with fingers to ensure adequate flushing. Promptly call a physician.Skin contactRinse skin thoroughly with large amounts of water. Remove contaminated clothing and shoes and call a physician.InhalationImmediately relocate self or casualty to fresh air. If breathing is difficult, give cardiopulmonary resuscitation (CPR). Avoid mouth-to-mouth resuscitation.IngestionWash out mouth with water; Do NOT induce vomiting; call a physician.4.2 Most important symptoms and effects, both acute and delayedThe most important known symptoms and effects are described in the labelling (see section 2.2).4.3 Indication of any immediate medical attention and special treatment neededTreat symptomatically.5. FIRE FIGHTING MEASURES5.1 Extinguishing mediaSuitable extinguishing mediaUse water spray, dry chemical, foam, and carbon dioxide fire extinguisher.5.2 Special hazards arising from the substance or mixtureDuring combustion, may emit irritant fumes.5.3 Advice for firefightersWear self-contained breathing apparatus and protective clothing.6. ACCIDENTAL RELEASE MEASURES6.1 Personal precautions, protective equipment and emergency proceduresUse full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.Refer to protective measures listed in sections 8.6.2 Environmental precautionsTry to prevent further leakage or spillage. Keep the product away from drains or water courses.6.3 Methods and materials for containment and cleaning upAbsorb solutions with finely-powdered liquid-binding material (diatomite, universal binders); Decontaminate surfaces and equipment by scrubbing with alcohol; Dispose of contaminated material according to Section 13.7. HANDLING AND STORAGE7.1 Precautions for safe handlingAvoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation. Use only in areas with appropriate exhaust ventilation.7.2 Conditions for safe storage, including any incompatibilitiesKeep container tightly sealed in cool, well-ventilated area. Keep away from direct sunlight and sources of ignition.Recommended storage temperature:Powder-20°C 3 years4°C 2 yearsIn solvent-80°C 6 months-20°C 1 monthShipping at room temperature if less than 2 weeks.7.3 Specific end use(s)No data available.8. EXPOSURE CONTROLS/PERSONAL PROTECTION8.1 Control parametersComponents with workplace control parametersThis product contains no substances with occupational exposure limit values.8.2 Exposure controlsEngineering controlsEnsure adequate ventilation. Provide accessible safety shower and eye wash station.Personal protective equipmentEye protection Safety goggles with side-shields.Hand protection Protective gloves.Skin and body protection Impervious clothing.Respiratory protection Suitable respirator.Environmental exposure controls Keep the product away from drains, water courses or the soil. Cleanspillages in a safe way as soon as possible.9. PHYSICAL AND CHEMICAL PROPERTIES9.1 Information on basic physical and chemical propertiesAppearance White to off-white (Solid)Odor No data availableOdor threshold No data availablepH No data availableMelting/freezing point No data availableBoiling point/range No data availableFlash point No data availableEvaporation rate No data availableFlammability (solid, gas)No data availableUpper/lower flammability or explosive limits No data availableVapor pressure No data availableVapor density No data availableRelative density No data availableWater Solubility No data availablePartition coefficient No data availableAuto-ignition temperature No data availableDecomposition temperature No data availableViscosity No data availableExplosive properties No data availableOxidizing properties No data available9.2 Other safety informationNo data available.10. STABILITY AND REACTIVITY10.1 ReactivityNo data available.10.2 Chemical stabilityStable under recommended storage conditions.10.3 Possibility of hazardous reactionsNo data available.10.4 Conditions to avoidNo data available.10.5 Incompatible materialsStrong acids/alkalis, strong oxidising/reducing agents.10.6 Hazardous decomposition productsUnder fire conditions, may decompose and emit toxic fumes.Other decomposition products - no data available.11.TOXICOLOGICAL INFORMATION11.1 Information on toxicological effectsAcute toxicityClassified based on available data. For more details, see section 2Skin corrosion/irritationClassified based on available data. For more details, see section 2Serious eye damage/irritationClassified based on available data. For more details, see section 2Respiratory or skin sensitizationClassified based on available data. For more details, see section 2Germ cell mutagenicityClassified based on available data. For more details, see section 2CarcinogenicityIARC: No component of this product present at a level equal to or greater than 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.ACGIH: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by ACGIH.NTP: No component of this product present at a level equal to or greater than 0.1% is identified as a anticipated or confirmed carcinogen by NTP.OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA.Reproductive toxicityClassified based on available data. For more details, see section 2Specific target organ toxicity - single exposureClassified based on available data. For more details, see section 2Specific target organ toxicity - repeated exposureClassified based on available data. For more details, see section 2Aspiration hazardClassified based on available data. For more details, see section 212. ECOLOGICAL INFORMATION12.1 ToxicityNo data available.12.2 Persistence and degradabilityNo data available.12.3 Bioaccumlative potentialNo data available.12.4 Mobility in soilNo data available.12.5 Results of PBT and vPvB assessmentPBT/vPvB assessment unavailable as chemical safety assessment not required or not conducted.12.6 Other adverse effectsNo data available.13. DISPOSAL CONSIDERATIONS13.1 Waste treatment methodsProductDispose substance in accordance with prevailing country, federal, state and local regulations.Contaminated packagingConduct recycling or disposal in accordance with prevailing country, federal, state and local regulations.14. TRANSPORT INFORMATIONDOT (US)This substance is considered to be non-hazardous for transport.IMDGUN number: 3077Class: 9Packing group: IIIEMS-No: F-A, S-FProper shipping name: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.Marine pollutant: Marine pollutantIATAUN number: 3077Class: 9Packing group: IIIProper shipping name: Environmentally hazardous substance, solid, n.o.s.15. REGULATORY INFORMATIONSARA 302 Components:No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.SARA 313 Components:This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.SARA 311/312 Hazards:No SARA Hazards.Massachusetts Right To Know Components:No components are subject to the Massachusetts Right to Know Act.Pennsylvania Right To Know Components:No components are subject to the Pennsylvania Right to Know Act.New Jersey Right To Know Components:No components are subject to the New Jersey Right to Know Act.California Prop. 65 Components:This product does not contain any chemicals known to State of California to cause cancer, birth defects, or anyother reproductive harm.16. OTHER INFORMATIONCopyright 2017 MedChemExpress. The above information is correct to the best of our present knowledge but does not purport to be all inclusive and should be used only as a guide. The product is for research use only and for experienced personnel. It must only be handled by suitably qualified experienced scientists in appropriately equipped and authorized facilities. The burden of safe use of this material rests entirely with the user. MedChemExpress disclaims all liability for any damage resulting from handling or from contact with this product.Caution: Product has not been fully validated for medical applications. For research use only.Tel: 609-228-6898 Fax: 609-228-5909 E-mail: tech@Address: 1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852, USA。