免疫学和微生物学医疗器械中英文

西西

Immunology and Microbiology Devices免疫学和微生物学医疗器械中英文对照
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
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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