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