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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?br /> 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 |
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IP卡
狗仔卡
发表于 2011-1-10 19:05:52
提升卡
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发表于 2011-8-22 13:43:24
