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肌红蛋白检测试剂盒（胶乳增强免疫比浊法）

国产有效注册第二类

产品名称：

肌红蛋白检测试剂盒（胶乳增强免疫比浊法）

注册人名称：

东软威特曼生物科技（南京）有限公司

苏械注准20182400384

注册人住所：

南京市雨花台区西善桥南路108号2号楼

批准(备案)日期：

2022-07-01

有效期至：

2028-02-04

结构及组成：

R1: 甘氨酸缓冲液（pH9.0）100mmol/LR2: 羊抗人肌红蛋白抗体胶乳颗粒0.18% 注：不同批号之间的各组分不可以互换。

适用范围：

用于体外定量检测人血清中肌红蛋白的含量。

生产地址：

南京市雨花台区西善桥南路108号2号楼

型号规格：

80mL/盒 (R1:1×60mL、R2:1×20mL；R1:2×30mL、R2:1×20mL；R1:2×30mL、R2:2×10mL）100mL/盒(R1:1×75mL、R2:1×25mL；R1:2×37.5mL、R2:1×25mL；R1:3×25mL、R2:2×12.5mL；R1:1×75mL、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；R1:2×75mL、R2:1×50mL；R1:3×50mL、R2:1×50mL；R1:4×37.5mL、R2:2×25mL；R1:6×25mL、R2:4×12.5mL；R1:3×50mL、R2:2×25mL)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；R1:3×75mL、R2:1×75mL；R1:5×45mL、R2:3×25mL；R1:5×45mL、R2:2×37.5mL；R1:6×37.5mL、R2:3×25mL；R1:3×75mL、R2:5×15mL)160T，400T，800T，1200T

产品储存条件及有效期：

2~8℃避光保存，生产日期起12个月内稳定。开瓶后2~8℃避光保存可稳定1个月。

管理类别：

第二类

备注：

原注册证号：苏械注准20182400384