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东软威特曼生物科技(南京)有限公司

境内医疗器械(注册) — “苏械注准20172400186”基本信息
注册证编号苏械注准20172400186 [查看相关产品信息]
注册人名称东软威特曼生物科技(南京)有限公司[查看公司信息]
注册人住所南京市雨花台区西善桥南路108号2号楼
生产地址南京市雨花台区西善桥南路108号2号楼
产品名称总胆汁酸检测试剂盒(速率法)
管理类别第二类
型号规格80mL/盒(R1:1×60mL、R2:1×20mL;R1:2×30mL、R2:1×20mL)100mL/盒(R1:1×75mL、R2:1×25mL;R1:2×37.5mL、R2:1×25mL;R1:3×25mL、 R2:2×12.5mL)160mL/盒(R1:2×60mL、R2:2×20mL;R1:3×40mL、R2:2×20mL)200mL/盒(R1:2×75mL、R2:2×25mL;R1:3×50mL、R2:1×50mL;R1:4×37.5mL、 R2:2×25mL;R1:3×50mL、R2:2×25mL; R1:2×75mL、R2:1×50mL; R1:6×25mL、R2:4×12.5mL)240mL/盒(R1:3×60mL、R2:3×20mL;R1:5×36mL、R2:3×20mL;R1:4×45mL、 R2:3×20mL)300mL/盒(R1:3×75mL、R2:3×25mL;R1:5×45mL、R2:3×25mL;R1:5×45mL、 R2:2×37.5mL;R1:6×37.5mL、R2:3×25mL;R1:3×75mL、R2:1×75mL)
结构及组成/主要组成成分试剂1: 两性离子缓冲溶液(Good’s缓冲液)[主要组成:N-(2-乙酰氨基)-2-氨基乙磺酸] 120mmol/L pH 6.5。试剂2:3α-羟基类固醇脱氢酶(3α-HSD) 12.5KU/L,硫代辅酶I(Thio-NAD)6.1g/L。 注:不同批号之间的各组分不可以互换 。
适用范围/预期用途用于人血清或血浆中总胆汁酸含量的体外定量测定。
审批部门江苏省药品监督管理局
批准日期2021/8/27
生效日期2021/8/27
有效期至2026/8/26
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