| 注册证编号 | 苏械注准20172400175 [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 | 视黄醇结合蛋白检测试剂盒（胶乳增强免疫透射比浊法） |
| 管理类别 | 第二类 |
| 型号规格 | 50mL/盒(R1:1×37.5mL、R2:1×12.5mL) 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；R1:1×75mL、R2:2×12.5mL； R1:5×15mL、R2:5×5mL)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)120T，300T，600T，900T |
| 结构及组成/主要组成成分 | R1: 磷酸盐缓冲液(PBS缓冲液)0.1mol/L PH 7.4，表面活性剂 2‰，叠氮化钠（NaN3） 1‰，聚乙二醇（PEG）6g/LR2: 磷酸盐缓冲液(PBS缓冲液)0.1mol/L PH 7.4，羊抗人RBP-IgG抗体胶乳颗粒0.25%，叠氮化钠（NaN3）1‰ 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视黄醇结合蛋白的浓度。 |
| 审批部门 | 江苏省药品监督管理局 |
| 批准日期 | 2021/8/13 |
| 生效日期 | 2021/8/13 |
| 有效期至 | 2026/8/12 |
