免疫学和微生物学器械

医疗器械中英文对照－－免疫学和微生物学器械 (Immunology and Microbiology Devices) （《联邦规章典集》第21篇第866部[21CFR866]） 目录 节号 中译文 原英文 A 亚部――总则（General Provisions ） 866.1 范围 Scope 866.3 有关上市前批准生效日期的要求 Effective dates of requirement for premarket approval 866.9 联邦食品、药品和化妆品法（Federal Food,

Drug, and Cosmetic Act ，FDCA ）第510（k ）节的豁免限制

Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). B 亚部――诊断器械（Diagnostic Devices ） 866.1620 抗菌敏感性测试盘 Antimicrobial susceptibility test disc 866.1640 抗菌敏感性测试粉 Antimicrobial susceptibility test powder

866.1645 全自动短期孵化周期抗菌敏感性系统 Fully automated short-term incubation cycle

antimicrobial susceptibility system

866.1700 抗菌敏感性测试用培养基 Culture medium for antimicrobial susceptibility tests C 亚部――微生物学器械（Microbiology Devices ） 866.2050 葡萄糖球菌类抗生素 Staphylococcal typing bacteriophage 866.2120 厌氧室 Anaerobic chamber 866.2160 凝固酶血浆 Coagulase plasma 866.2170 自动菌落计数器 Automated colony counter 866.2180 手动菌落计数器 Manual colony counter 866.2300 多用途培养基 Multipurpose culture medium 866.2320 鉴别培养基 Differential culture medium 866.2330 增菌(富集) 培养基 Enriched culture medium 866.2350 微生物鉴定培养基 Microbiological assay culture medium 866.2360 选择性培养基 Selective culture medium 866.2390 转运培养基 Transport culture medium 866.2410 致病奈瑟球菌培养基 Culture medium for pathogenic Neisseria spp 866.2420 淋病氧化酶筛选检测 Oxidase screening test for gonorrhea 866.2440 自动介质分发和堆积器械 Automated medium dispensing and stacking device 866.2450 培养基补充装置 Supplement for culture media 866.2480 培养基质量控制试剂盒 Quality control kit for culture media 866.2500 微量滴定稀释和分配装置 Microtiter diluting and dispensing device 866.2540 微生物培养器 Microbiological incubator 866.2560 微生物生长监视器 Microbial growth monitor 866.2580 气体产生装置 Gas-generating device 866.2600 伍德荧光灯 Wood`s fluorescent lamp 866.2660 微生物区分和标识装置 Microorganism differentiation and identification device 866.2850 自动读带器 Automated zone reader 866.2900 微生物标本收集和运送装置 Microbiological specimen collection and transport device D 亚部 ――血清试剂（Serological Reagents ） 866.3010 乙酸钙不动杆菌血清试剂 Acinetobacter calcoaceticus serological reagents 866.3020 腺病毒血清试剂 Adenovirus serological reagents

866.3035 亚利桑那菌血清试剂Arizona spp. serological reagents

866.3040 曲霉菌血清试剂Aspergillus spp. serological reagents

866.3060 皮炎芽生菌血清试剂Blastomyces dermatitidis serological reagents

866.3065 博代氏(杆)菌血清试剂Bordetella spp. serological reagents

866.3085 布鲁氏菌血清试剂Brucella spp. serological reagents

866.3110 胚胎弯曲杆菌血清试剂Campylobacter fetus serological reagents

866.3120 衣原体血清试剂Chlamydia serological reagents

866.3125 柠檬酸菌血清试剂Citrobacter spp. serological reagents

866.3135 球孢子菌血清试剂Coccidioides immitis serological reagents

866.3140 棒状杆菌血清试剂Corynebacterium spp. serological reagents

866.3145 柯萨奇病毒血清试剂Coxsackievirus serological reagents

866.3165 隐球菌赘生物血清试剂Cryptococcus neoformans serological reagents

866.3175 细胞巨化病毒血清试剂Cytomegalovirus serological reagents

866.3200 棘球绦虫菌血清试剂Echinococcus spp. serological reagents

866.3205 艾柯病毒血清试剂Echovirus serological reagents

866.3220 内阿米巴属组织溶解菌血清试剂Entamoeba histolytica serological reagents

866.3235 爱泼斯坦－巴尔病毒血清试剂Epstein-Barr virus serological reagents

866.3240 马脑脊髓炎病毒血清试剂Equine encephalomyelitis virus serological reagents 866.3250 丹毒丝菌血清试剂Erysipelothrix rhusiopathiae serological reagents

866.3255 埃希氏大肠杆菌血清试剂Escherichia coli serological reagents

866.3270 黄质菌血清试剂Flavobacterium spp. serological reagents

866.3280 土拉弗朗西斯菌血清试剂Francisella tularensis serological reagents

866.3290 淋菌抗体检测(GA T) Gonococcal antibody test (GAT)

866.3300 嗜血杆菌血清试剂Haemophilus spp. serological reagents

866.3305 单纯疱疹病毒血清试剂Herpes simplex virus serological reagents

866.3320 荚膜组织胞浆菌血清试剂Histoplasma capsulatum serological reagents

866.3330 流感病毒血清试剂Influenza virus serological reagents

866.3340 克雷博氏菌血清试剂Klebsiella spp. serological reagents

866.3350 钩端螺旋体菌血清试剂Leptospira spp. serological reagents

866.3355 利斯特氏菌血清试剂Listeria spp. serological reagents

866.3360 脉络丛脑膜炎淋巴细胞病毒血清试剂Lymphocytic choriomeningitis virus serological reagents 866.3370 肺结核分支杆菌荧光免疫检验试剂Mycobacterium tuberculosis immunofluorescent reagents 866.3375 支原菌血清试剂Mycoplasma spp. serological reagents

866.3380 腮腺炎病毒血清试剂Mumps virus serological reagents

866.3390 奈瑟球菌直接血清检测试剂Neisseria spp. direct serological test reagents

866.3400 副流感病毒血清试剂Parainfluenza virus serological reagents

866.3405 脊髓灰质炎病毒血清试剂Poliovirus serological reagents

866.3410 变形杆菌血清试剂Proteus spp. (Weil-Felix) serological reagents

866.3415 假单胞菌血清试剂Pseudomonas spp. serological reagents

866.3460 狂犬病病毒荧光免疫检验试剂Rabiesvirus immunofluorescent reagents

866.3470 呼吸道肠道病毒血清试剂Reovirus serological reagents

866.3480 呼吸合胞体病毒血清试剂Respiratory syncytial virus serological reagents

866.3490 鼻病毒血清试剂Rhinovirus serological reagents

866.3500 立克次氏体属细菌血清试剂Rickettsia serological reagents