| 产品名称 | 肌红蛋白检测试剂盒（胶乳增强免疫比浊法） |
|---|---|
| 结构及组成/主要组成成分 | 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/预期用途 | 用于体外定量检测人血清中肌红蛋白的含量。 |
| 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。 |
| 注册证编号 | 苏械注准20182400384 |
| 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 | 原注册证号：苏械注准20182400384 |
| 批准日期 | 2022-07-01 |
| 有效期至 | 2028-02-04 |
| 编码代号2018 | 6840IVD |
| 管理分类 | Ⅱ |
| 企业联系电话 | 025-86430100 |
| 网址 | 暂无权限 |
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