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(GAT) |
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 |
866.3510 |
风疹病毒血清试剂 |
Rubella virus serological reagents |
866.3520 |
麻疹病毒血清试剂 |
Rubeola (measles) virus serological reagents |
866.3550 |
沙门氏菌血清试剂 |
Salmonella spp. serological reagents |
866.3600 |
血吸虫菌血清试剂 |
Schistosoma spp. serological reagents |
866.3610 |
内毒素化验 |
Endotoxin assay |
866.3630 |
沙雷氏菌血清试剂 |
Serratia spp. serological reagents |
866.3660 |
志贺氏菌血清试剂 |
Shigella spp. serological reagents |
866.3680 |
申克孢子丝菌血清试剂 |
Sporothrix schenckii serological reagents |
866.3700 |
奥里斯葡萄球菌血清试剂 |
Staphylococcus aureus serological reagents |
866.3720 |
链球菌外酵素试剂 |
Streptococcus spp. exoenzyme reagents |
866.3740 |
链球菌血清试剂 |
Streptococcus spp. serological reagents |
866.3780 |
鼠弓形体血清试剂 |
Toxoplasma gondii serological reagents |
866.3820 |
梅毒螺旋体非密螺旋体检测试剂 |
Treponema pallidum nontreponemal test reagents |
866.3830 |
梅毒螺旋体密螺旋体检测试剂 |
Treponema pallidum treponemal test reagents |
866.3850 |
旋毛虫血清试剂 |
Trichinella spiralis serological reagents |
866.3870 |
锥虫菌血清试剂 |
Trypanosoma spp. serological reagents |
866.3900 |
水痘-带状疱疹病毒血清试剂 |
Varicella-zoster virus serological reagents |
866.3930 |
霍乱弧菌血清试剂 |
Vibrio cholerae serological reagents |
866.3940 |
西尼罗病毒血清试剂 |
West Nile virus serological reagents |
E亚部――免疫学实验室设备和试剂(Immunology Laboratory Equipment and Reagents) |
866.4100 |
补体试剂 |
Complement reagent |
866.4500 |
免疫电泳计 |
Immunoelectrophoresis equipment |
866.4520 |
免疫荧光计 |
Immunofluorometer equipment |
866.4540 |
免疫散射浊度计 |
Immunonephelometer equipment |
866.4600 |
Ouchterlony琼脂平板 |
Ouchterlony agar plate |
866.4800 |
放射状免疫扩散盘 |
Radial immunodiffusion plate |
866.4830 |
火箭免疫电泳计 |
Rocket immunoelectrophoresis equipment |
866.4900 |
支撑凝胶 |
Support gel |
F亚部――免疫学检测系统(Immunological Test Systems) |
866.5040 |
白蛋白免疫学检测系统 |
Albumin immunological test system |
866.5060 |
前白蛋白免疫学检测系统 |
Prealbumin immunological test system |
866.5065 |
人同种异形标记物免疫学检测系统 |
Human allotypic marker immunological test system |
866.5080 |
α-1抗胰凝乳蛋白酶免疫学检测系统 |
Alpha-1-antichymotrypsin immunological test system |
866.5090 |
抗线粒体抗体免疫学检测系统 |
Antimitochondrial antibody immunological test system |
866.5100 |
抗细胞核抗体免疫学检测系统 |
Antinuclear antibody immunological test system |
866.5110 |
抗体壁抗体免疫学检测系统 |
Antiparietal antibody immunological test system |
866.5120 |
抗平滑肌抗体免疫学检测系统 |
Antismooth muscle antibody immunological test system |
866.5130 |
α-1抗胰岛素免疫学检测系统 |
Alpha-1-antitrypsin immunological test system |
866.5150 |
Bence-Jones蛋白质免疫学检测系统 |
Bence-Jones proteins immunological test system |
866.5160 |
β-球蛋白免疫学检测系统 |
Beta-globulin immunological test system |
866.5170 |
母奶免疫学检测系统 |
Breast milk immunological test system |
866.5200 |
脱水碳B和C免疫学检测系统 |
Carbonic anhydrase B and C immunological test system |
866.5210 |
血浆铜蓝蛋白免疫学检测系统 |
Ceruloplasmin immunological test system |
866.5220 |
科恩分部分离法II免疫学检测系统 |
Cohn fraction II immunological test system |
866.5230 |
初乳免疫学检测系统 |
Colostrum immunological test system |
866.5240 |
补体成分免疫学检测系统 |
Complement components immunological test system |
866.5250 |
补体C1抑制剂(灭活剂)免疫学检测系统 |
Complement C1 inhibitor (inactivator) immunological test system |
866.5260 |
补体C3b灭活剂免疫学检测系统 |
Complement C3b inactivator immunological test system |
866.5270 |
C-反应蛋白质免疫学检测系统 |
C-reactive protein immunological test system |
866.5320 |
血清灭菌蛋白因子B免疫学检测系统 |
Properdin factor B immunological test system |
866.5330 |
因子XIII、A、S免疫学检测系统 |
Factor XIII, A, S, immunological test system |
866.5340 |
铁蛋白免疫学检测系统 |
Ferritin immunological test system |
866.5350 |
血纤维蛋白肽A免疫学检测系统 |
Fibrinopeptide A immunological test system |
866.5360 |
科恩分部分离法IV免疫学检测系统 |
Cohn fraction IV immunological test system |
866.5370 |
科恩分部分离法V免疫学检测系统 |
Cohn fraction V immunological test system |
866.5380 |
游离分泌成分免疫学检测系统 |
Free secretory component immunological test system |
866.5400 |
α球蛋白免疫学检测系统 |
Alpha-globulin immunological test system |
866.5420 |
α-1糖蛋白免疫学检测系统 |
Alpha-1-glycoproteins immunological test system |
866.5425 |
α-2糖蛋白免疫学检测系统 |
Alpha-2-glycoproteins immunological test system |
866.5430 |
β-2糖蛋白I免疫学检测系统 |
Beta-2-glycoprotein I immunological test system |
866.5440 |
β-2糖蛋白III免疫学检测系统 |
Beta-2-glycoprotein III immunological test system |
866.5460 |
触珠蛋白免疫学检测系统 |
Haptoglobin immunological test system |
866.5470 |
血色素免疫学检测系统 |
Hemoglobin immunological test system |
866.5490 |
血液结合素免疫学检测系统 |
Hemopexin immunological test system |
866.5500 |
超敏性肺炎免疫学检测系统 |
Hypersensitivity pneumonitis immunological test system |
866.5510 |
免疫球蛋白A、G、M、D、E免疫学检测系统 |
Immunoglobulins A, G, M, D, and E immunological test system |
866.5520 |
免疫球蛋白G(特定Fab片段)免疫学检测系统 |
Immunoglobulin G (Fab fragment specific) immunological test system |
866.5530 |
免疫球蛋白G(特定Fc片段)免疫学检测系统 |
Immunoglobulin G (Fc fragment specific) immunological test system |
866.5540 |
免疫球蛋白G(特定Fd片段)免疫学检测系统 |
Immunoglobulin G (Fd fragment specific) immunological test system |
866.5550 |
免疫球蛋白(特定轻链)免疫学检测系统 |
Immunoglobulin (light chain specific) immunological test system |
866.5560 |
乳脱氢酶免疫学检测系统 |
Lactic dehydrogenase immunological test system |
866.5570 |
乳铁传递蛋白免疫学检测系统 |
Lactoferrin immunological test system |
866.5580 |
α-1脂蛋白免疫学检测系统 |
Alpha-1-lipoprotein immunological test system |
866.5590 |
脂蛋白X免疫学检测系统 |
Lipoprotein X immunological test system |
866.5600 |
低密度脂蛋白免疫学检测系统 |
Low-density lipoprotein immunological test system |
866.5620 |
α-2巨球蛋白免疫学检测系统 |
Alpha-2-macroglobulin immunological test system |
866.5630 |
β-2微球蛋白免疫学检测系统 |
Beta-2-microglobulin immunological test system |
866.5640 |
传染性单核细胞增多症免疫学检测系统 |
Infectious mononucleosis immunological test system |
866.5660 |
多发自身抗体免疫学检测系统 |
Multiple autoantibodies immunological test system |
866.5680 |
肌血球素免疫学检测系统 |
Myoglobin immunological test system |
866.5700 |
人的全血浆或血清免疫学检测系统 |
Whole human plasma or serum immunological test system |
866.5715 |
血纤维蛋白溶酶原免疫学检测系统 |
Plasminogen immunological test system |
866.5735 |
凝血素免疫学检测系统 |
Prothrombin immunological test system |
866.5750 |
放射变应性吸附(RAST)免疫学检测系统 |
Radioallergosorbent (RAST) immunological test system |
866.5765 |
视黄醇结合蛋白质免疫学检测系统 |
Retinol-binding protein immunological test system |
866.5775 |
类风湿因子免疫学检测系统 |
Rheumatoid factor immunological test system |
866.5785 |
抗酵母麦酒(S麦酒)抗体(ASCA)检测系统 |
Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems |
866.5800 |
精液免疫学检测系统 |
Seminal fluid (sperm) immunological test system |
866.5820 |
全身红斑狼疮免疫学检测系统 |
Systemic lupus erythematosus immunological test system |
866.5860 |
总脊髓液免疫学检测系统 |
Total spinal fluid immunological test system |
866.5870 |
甲状腺自身抗体免疫学检测系统 |
Thyroid autoantibody immunological test system |
866.5880 |
铁传递蛋白免疫学检测系统 |
Transferrin immunological test system |
866.5890 |
η-α胰岛素抑制剂免疫学检测系统 |
Inter-alpha trypsin inhibitor immunological test system |
G亚部 ――与瘤有关的抗原免疫学检测系统(Tumor Associated Antigen immunological Test Systems) |
866.6010 |
与瘤有关的抗原免疫学检测系统 |
Tumor-associated antigen immunological test system |
866.6020 |
免疫磁性循环癌细胞选择和列举系统 |
Immunomagnetic circulating cancer cell selection and enumeration system |