北京译海腾飞翻译公司
联系电话:010-81534401,65677906
公司传真:010-65677906
项目经理:13241835386
联系信箱:81534401@163.com
联系地址:北京市朝阳区南郎家园1号大北写字楼512室(国贸桥东南角,紧邻招商局、海航大厦)
邮政编码:100022
公司网址:http://www.bjyhtf.com
(《联邦规章典集》第21篇第864部[21CFR864])
节号 | 中译文 | 原英文 |
A亚部――总则(General Provisions) | ||
864.1 | 范围 | Scope |
864.3 | 有关上市前批准生效日期的要求 | Effective dates of requirement for premarket approval |
864.9 | 联邦食品、药品和化妆品法第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――生物染色(Biological Stains) | ||
864.1850 | 染料和化学溶液染色剂 | Dye and chemical solution stains |
864.1860 | 免疫组织化学试剂和试剂盒 | Immunohistochemistry reagents and kits |
C亚部――细胞和组织培养产品(Cell and Tissue Culture Products) | ||
864.2220 | 人造细胞和组织培养基及成分 | Synthetic cell and tissue culture media and components |
864.2240 | 细胞和组织培养供应品及设备 | Cell and tissue culture supplies and equipment |
864.2260 | 染色体培养试剂盒 | Chromosome culture kit |
864.2280 | 培养的动物和人体的细胞 | Cultured animal and human cells |
864.2360 | 支原体检测介质和成分 | Mycoplasma detection media and components |
864.2800 | 动物和人的血清 | Animal and human sera |
864.2875 | 平衡盐溶液或配方 | Balanced salt solutions or formulations |
D亚部――病理学检测设备和附件(Pathology Instrumentation and Accessories) | ||
864.3010 | 组织处理装置 | Tissue processing equipment |
864.3250 | 标本运送和储存容器 | Specimen transport and storage container |
864.3260 | 用于药物滥用检测的OTC检测样品收集系统 | OTC test sample collection systems for drugs of abuse testing |
864.3300 | 细胞离心机 | Cytocentrifuge |
864.3400 | 显微切片封接器械 | Device for sealing microsections |
864.3600 | 显微镜及其附件 | Microscopes and accessories |
864.3800 | 自动载玻片着色器 | Automated slide stainer |
864.3875 | 自动组织处理器 | Automated tissue processor |
E亚部――标本制备试剂(Specimen Preparation Reagents) | ||
864.4010 | 通用试剂 | General purpose reagent |
864.4020 | 被分析物特效试剂 | Analyte specific reagents |
864.4400 | 酶制剂 | Enzyme preparations |
F亚部――自动和半自动血液学装置 | ||
864.5200 | 自动细胞计数器 | Automated cell counter |
864.5220 | 自动差分细胞计数器 | Automated differential cell counter |
864.5240 | 自动血细胞稀释器 | Automated blood cell diluting apparatus |
864.5260 | 自动细胞定位装置 | Automated cell-locating device |
864.5300 | 红细胞指数器械 | Red cell indices device |
864.5350 | 微沉淀离心机 | Microsedimentation centrifuge |
864.5400 | 凝结装置 | Coagulation instrument |
864.5425 | 体外凝结研究用多用途系统 | Multipurpose system for in vitro coagulation studies |
864.5600 | 自动血球容积计 | Automated hematocrit instrument |
864.5620 | 自动血色素系统 | Automated hemoglobin system |
864.5680 | 自动肝磷脂分析仪 | Automated heparin analyzer |
864.5700 | 自动血小板聚集系统 | Automated platelet aggregation system |
864.5800 | 自动沉降速率装置 | Automated sedimentation rate device |
864.5850 | 自动载玻片旋转器 | Automated slide spinner |
864.5950 | 血液容积测量装置 | Blood volume measuring device |
G亚部――手动血液学装置(Manual Hematology Devices) | ||
864.6100 | 出血时间测定装置 | Bleeding time device |
864.6150 | 毛细血液收集管 | Capillary blood collection tube |
864.6160 | 手动血细胞计数装置 | Manual blood cell counting device |
864.6400 | 血球容积测量装置 | Hematocrit measuring device |
864.6550 | 潜隐血检测 | Occult blood test |
864.6600 | 渗透脆性检测 | Osmotic fragility test |
864.6650 | 血小板粘附检测 | Platelet adhesion test |
864.6675 | 血小板聚集测量计 | Platelet aggregometer |
864.6700 | 红血球沉降速率检测 | Erythrocyte sedimentation rate test |
H亚部――血液学试剂盒和工具包(Hematology Kits and Packages) | ||
864.7040 | 三磷酸腺苷释放化验 | Adenosine triphosphate release assay |
864.7060 | 抗血栓III化验 | Antithrombin III assay |
864.7100 | 红血球酶化验 | Red blood cell enzyme assay |
864.7140 | 活性全血凝固时间检测 | Activated whole blood clotting time tests |
864.7250 | 促红细胞生成素化验 | Erythropoietin assay |
864.7275 | 真球蛋白消散时间检测 | Euglobulin lysis time tests |
864.7280 | 因子V莱顿DNA转变探测系统 | Factor V Leiden DNA mutation detection systems |
864.7290 | 因子缺乏检测 | Factor deficiency test |
864.7300 | 纤维单体副凝检测 | Fibrin monomer paracoagulation test |
864.7320 | 纤维蛋白原/纤维蛋白降解产物化验 | Fibrinogen/fibrin degradation products assay |
864.7340 | 纤维蛋白原测定系统 | Fibrinogen determination system |
864.7360 | 红血球葡萄糖-6-磷酸脱氢酶化验 | Erythrocytic glucose-6- phosphate dehydrogenase assay |
864.7375 | 谷胱甘肽还原酶化验 | Glutathione reductase assay |
864.7400 | 血色素A2化验 | Hemoglobin A2 assay |
864.7415 | 异常血红蛋白化验 | Abnormal hemoglobin assay |
864.7425 | 羧络血红蛋白化验 | Carboxyhemoglobin assay |
864.7440 | 血色素电泳分析系统 | Electrophoretic hemoglobin analysis system |
864.7455 | 胎儿血红蛋白化验 | Fetal hemoglobin assay |
864.7470 | 糖基化血色素化验 | Glycosylated hemoglobin assay |
864.7490 | 含硫血色素化验 | Sulfhemoglobin assay |
864.7500 | 全血血色素化验 | Whole blood hemoglobin assays |
864.7525 | 肝磷脂化验 | Heparin assay |
864.7660 | 白细胞碱性磷酸酶检测 | Leukocyte alkaline phosphatase test |
864.7675 | 白血病过氧化物酶检测 | Leukocyte peroxidase test |
864.7695 | 血小板因子4放射性免疫测定 | Platelet factor 4 radioimmunoassay |
864.7720 | 凝血素消耗量检测 | Prothrombin consumption test |
864.7735 | 凝血素第七因子检测和凝血试验 | Prothrombin-proconvertin test and thrombotest |
864.7750 | 凝血素时间检测 | Prothrombin time test |
864.7825 | 镰状细胞检测 | Sickle cell test |
864.7875 | 凝血酶时间检测 | Thrombin time test |
864.7900 | 促凝血酶原激酶生成检测 | Thromboplastin generation test |
864.7925 | 局部促凝血酶原激酶时间检测 | Partial thromboplastin time tests |
I亚部――血液学试剂(Hematology Reagents) | ||
864.8100 | 大具窍蝮蛇试剂 | Bothrops atrox reagent |
864.8150 | 细胞指数定标器 | Calibrator for cell indices |
864.8165 | 血色素或血球容积测量定标器 | Calibrator for hemoglobin or hematocrit measurement |
864.8175 | 血小板计数定标器 | Calibrator for platelet counting |
864.8185 | 红细胞和白细胞计数定标器 | Calibrator for red cell and white cell counting |
864.8200 | 血细胞稀释器 | Blood cell diluent |
864.8500 | 淋巴细胞分离介质 | Lymphocyte separation medium |
864.8540 | 红细胞溶解试剂 | Red cell lysing reagent |
864.8625 | 血液学质量控制混合剂 | Hematology quality control mixture |
864.8950 | 拉塞尔蛇毒试剂 | Russell viper venom reagent |
J亚部――在生产血液及血液制品的机构中使用的产品 | ||
864.9050 | 血库供应品 | Blood bank supplies |
864.9100 | 用于收集和处理血液及其成分的空容器 | Empty container for the collection and processing of blood and blood components |
864.9125 | 真空辅助式血液收集系统 | Vacuum-assisted blood collection system |
864.9145 | 冷冻血液处理系统 | Processing system for frozen blood |
864.9160 | 体外诊断用非人类的血型物 | Blood group substances of nonhuman origin for in vitro diagnostic use |
864.9175 | 血型和抗体自动检测系统 | Automated blood grouping and antibody test system |
864.9185 | 血型鉴定观察箱 | Blood grouping view box |
864.9195 | 血液混合装置和血液称量装置 | Blood mixing devices and blood weighing devices |
864.9205 | 血液和血浆加温装置 | Blood and plasma warming device |
864.9225 | 体外诊断用细胞冷冻设备和试剂 | Cell-freezing apparatus and reagents for in vitro diagnostic use |
864.9245 | 自动血细胞分离器 | Automated blood cell separator |
864.9275 | 体外诊断用血库离心机 | Blood bank centrifuge for in vitro diagnostic use |
864.9285 | 免疫血液学用自动细胞洗涤离心机 | Automated cell-washing centrifuge for immuno-hematology |
864.9300 | 自动库姆斯氏试验系统 | Automated Coombs test systems |
864.9320 | 用于比重测定的硫酸铜溶液 | Copper sulfate solution for specific gravity determinations |
864.9400 | 稳定酶溶液 | Stabilized enzyme solution |
864.9550 | 外源凝集素和保护素 | Lectins and protectins |
864.9575 | 用于血小板浓缩物储存的环境舱 | Environmental chamber for storage of platelet concentrate |
864.9600 | 体外诊断用增效剂 | Potentiating media for in vitro diagnostic use |
864.9650 | 血库试剂的质量控制试剂盒 | Quality control kit for blood banking reagents |
864.9700 | 血液储存的电冰箱和冷藏机 | Blood storage refrigerator and blood storage freezer |
864.9750 | 热封装置 | Heat-sealing device |
864.9875 | 转移装置 | Transfer set |