| 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（Automated and Semi-Automated Hematology Devices） |
| 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（Products Used in Establishments That Manufacture Blood and Blood Products） |
| 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 |
