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上海科华生物工程股份有限公司

境内医疗器械(注册) — “沪械注准20202400332”基本信息
注册证编号沪械注准20202400332 [查看相关产品信息]
注册人名称上海科华生物工程股份有限公司[查看公司信息]
注册人住所上海市徐汇区钦州北路1189号
生产地址上海市徐汇区钦州北路1189号
产品名称甘胆酸测定试剂盒(均相酶免疫法)
管理类别第二类
型号规格规格1(25mL): R1:1×20mL, R2:1×5mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格2(37.5mL): R1:1×30mL, R2:1×7.5mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格3(50mL): R1:1×40mL, R2:1×10mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格4(150mL): R1:2×60mL, R2:2×15mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格5(57mL): R1:1×43mL, R2:1×14mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格6(145mL): R1:2×54mL, R2:1×37mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格7(108mL): R1:2×40mL, R2:2×14mL;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格8(400T): R1:2×200T, R2:2×200T;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格9(600T): R1:2×300T, R2:1×600T;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格10(300T): R1:1×300T, R2:1×300T;校准品a:1×0.5mL, 校准品b:1×0.5mL, 校准品c:1×0.5mL, 校准品d:1×0.5mL, 校准品e:1×0.5mL, 校准品f:1×0.5mL;质控品L:1×1.0mL, 质控品H:1×1.0mL; 规格11(25mL): R1:1×20mL,R2:1×5mL; 规格12(37.5mL):R1:1×30mL,R2:1×7.5mL; 规格13(50mL):R1:1×40mL, R2:1×10mL; 规格14(150mL):R1:2×60mL,R2:2×15mL; 规格15(57mL):R1:1×43mL, R2:1×14mL; 规格16(145mL):R1:2×54mL,R2:1×37mL; 规格17(108mL):R1:2×40mL,R2:2×14mL; 规格18(400T):R1: 2×200T,R2:2×200T; 规格19(600T):R1:2×300T,R2:1×600T; 规格20(300T):R1:1×300T,R2:1×300T。
结构及组成/主要组成成分R1:Good’s缓冲液,6-磷酸葡萄糖,烟酰胺腺嘌呤二核苷磷酸,抗甘胆酸抗体,防腐剂; R2:柠檬酸缓冲液,6-磷酸葡萄糖脱氢酶-甘胆酸偶联物,防腐剂; 校准品:缓冲液,甘氨胆酸钠,防腐剂; 质控品:缓冲液,甘氨胆酸钠,防腐剂。
适用范围/预期用途本试剂供医疗机构用于体外定量检测人血清中甘胆酸(CG)的含量,作辅助诊断用。
审批部门上海市药品监督管理局
批准日期2020/7/14
生效日期2020/7/14
有效期至2025/7/13
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