| 产品名称 | 肌酐检测试剂盒(终点法) |
|---|---|
| 结构及组成/主要组成成分 | 试剂1：肌酸酶(CR) 24000 U/L，肌氨酸氧化酶(SOX)11000 U/L。试剂2：肌酐酶(CRN) 250000 U/L，4-氨基安替吡啉(4-AAP)0.61 g/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 | 本试剂用于人血清或血浆中肌酐含量的体外定量测定。 |
| 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；R1:2×75mL、R2:1×50mL；R1:6×25mL、R2:4×12.5mL ； R1:3×50mL、R2:2×25mL)240mL/盒(R1:5×36mL、R2:3×20mL；R1:4×45mL、R2:3×20mL； R1:3×60mL、R2:3×20mL)300mL/盒(R1:3×75mL、R2:3×25mL；R1:5×45mL、R2:3×25mL；R1:5×45mL、R2:2×37.5mL；R1:3×75mL、R2:1×75mL ；R1:6×37.5mL、R2:3×25mL) |
| 产品储存条件及有效期 | 试剂于2~8℃避光保存可稳定一年。开瓶后可稳定一个月。 |
| 注册证编号 | 苏械注准20172400216 |
| 注册人名称 | 东软威特曼生物科技（南京）有限公司 |
| 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 |
| 备注 | 原注册证苏食药监械(准)字2013第2400337号作废；医疗器械生产许可证号：苏食药监械生产许20020015号。 |
| 批准日期 | 2020-01-10 |
| 有效期至 | 2022-02-23 |
| 编码代号2018 | 暂无权限 |
| 管理分类 | 暂无权限 |
| 企业联系电话 | 暂无权限 |
| 网址 | 暂无权限 |
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