AS8351_HNMR_26534_MedChemExpress

合集下载

GeXP简介

GeXP简介

•Alignment
•Call scores
•Heterozygote Detection
2013/11/12
6
GeXP荧光系统
•GeXP更适合检测突变/杂合子: •波长越长,干扰越少 ,背景噪音低;
•650nm •laser •750nm •laser
•无10%的cut off把噪音,不会把10%以上杂合子去掉;
•NO Interference •from biological materials
7
个体化用药检测
KIT-Exon9
PDGFRA-exon12
EGFR突变检测
肿瘤药物对应相关基因的检测
药物名称 易瑞沙/特罗凯类 检测基因
EGFR-Exon18 突变 EGFR-Exon19 突变 EGFR-Exon21 突变 EGFR-Exon20突变 C-KIT-Exon9 突变 C-KIT-Exon11 突变 C-KIT-Exon13 突变 C-KIT-Exon17 突变 PDGFRα-Exon12 PDGFRα-Exon18 CYP2D6*10 多态性 XRCC1-Exon6 多态性 XRCC1-Exon10 多态性 ERCC1-codon118 多态性 MRP2-Exon10 多态性 BRCA1-Exon2 (女)多态性 BRCA1-Exon20 (女)多态性 XPD基因多态性 UGT1A1 *6 多态性 UGT1A1*28 多态性 DPYD*2A 多态性
伊马替尼 他莫昔芬
铂类
伊立替康 氟脲嘧啶类
HBV分型、耐药突变检测
2、片段分析
• 只需要研究长度,不需要知道具体序列 • 分别率为1bp
片段分析应用
STR/SSR
融合基因,可变剪切体

AU-5831生化分析性能验证报告

AU-5831生化分析性能验证报告

性能验证报告单位名称:AAAAA医院科室名称:检验科实验室:生化组仪器名称:贝克曼库尔特全自动生化分析仪型号规格:AU-5831仪器编号:SH027验证人员:审核人:批准人:验证日期:2012年11月26日—2012年12月12日AAAAA医院检验科性能验证报告目录碱性磷酸酶(ALP)方法学验证 (2)丙氨酸氨基转移酶(ALT)方法学验证 (9)载脂蛋白A1(apo AⅠ)方法学验证 (16)载脂蛋白B(apoB)方法学验证 (24)天冬氨酸氨基转移酶(AST)方法学验证 (31)总胆固醇(TC)方法学验证 (38)肌酸激酶(CK)方法学验证 (45)γ-谷氨酰基转移酶(GGT)方法学验证 (52)乳酸脱氢酶(LDH)方法学验证 (59)总胆红素(T-Bil)方法学验证 (66)甘油三酯(TG)方法学验证 (73)尿酸(UA)方法学验证 (80)白蛋白(Alb)方法学验证 (87)尿素(Urea)方法学验证 (96)肌酐(Cr)方法学验证 (105)葡萄糖(Glu)方法学验证 (114)总蛋白(TP)方法学验证 (123)碱性磷酸酶(ALP)方法学验证一.检测系统信息:项目:碱性磷酸酶(ALP)仪器名称:贝克曼库尔特全自动生化分析仪仪器型号: AU5831试剂及厂商:北京中生北控生物科技股份有限公司检测方法:速率法二.验证的相关参数:需验证参数厂商参数验证结果分析灵敏度(lower detectionlimit) 浓度为230U/L的ALP所引起的吸光度变化率(△A/min)应在0.020-0.090的范围内沿用厂商参数分析测量范围(AMR)1-1200U/L 已验证临床报告范围(CRR)1-16800U/L 根据厂家相关参数换算而来参考值区间(Expected values) 26-150U/L 已验证最大允许误差。

三.验证过程:1.精密度(Precision):1.1 批内精密度:●目的:考察方法的随机误差●标本来源:浓度分别处于正常和病理水平的混合新鲜临床标本,正常水平标本来源条码号:12061910922,12112810099,12112810107,12112810053 。

AZD7545_SDS_MedChemExpress

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。

国家药品监督管理局新冠相关注册产品2021

国家药品监督管理局新冠相关注册产品2021

2021.01.21 2026.01.20
7 国械注准20203400919 杭州众测生物科技有限公司 新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)
2020.11.30 2021.11.29
8 国械注准20203400184
迈克生物股份有限公司
新型冠状病毒2019-nCov核酸检测试剂盒(CRISPR免疫层析法)
11 国械注准20203400496
迈克生物股份有限公司
新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒(直接化学发光法) 2021.05.21 2026.05.20
12 国械注准20203400749 中山大学达安基因股份有限公司 新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)
24
国械注准20203400498
博奥赛斯(天津)生物科技有限 公司
新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒(化学发光法)
25 国械注准20203400240 珠海丽珠试剂股份有限公司 新型冠状病毒(2019-nCoV)IgM/IgG抗体检测试剂盒(胶体金法)
2021.03.18 2021.05.28 2020.12.15
2021.02.10 2026.02.09
9 国械注准20213400228 重庆中元汇吉生物技术有限公司 新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法)
2021.04.01 2026.03.31
10 国械注准20203400495 郑州安图生物工程股份有限公司 新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒(磁微粒化学发光法)2021.05.10 2026.05.09
国家药品监督管理局新冠相关检测产品注册证书统计(截止2021.11.23)
  1. 1、下载文档前请自行甄别文档内容的完整性,平台不提供额外的编辑、内容补充、找答案等附加服务。
  2. 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
  3. 3、如文档侵犯您的权益,请联系客服反馈,我们会尽快为您处理(人工客服工作时间:9:00-18:30)。
相关文档
最新文档