血液学和病理学医疗器械中英文对照

Hematology and Pathology Devices血液学和病理学医疗器械中英文对照
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苞(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www.hope.net.cn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
 体外诊断觲ww.hope.net.cn饫胄幕�
 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