| 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 |
