| 注册证号： | 苏械注准20172400223 | 分类目录： | 体外诊断试剂 |
| 注册公司： | 东软威特曼生物科技（南京）有限公司 | 代理公司： | 暂缺 |
| 规格型号： | 100mL盒(R1:1×75mL、R2:1×25mL；R1:2×37.5mL、R2:1×25mL；R1:3×25mL、 R2:2×12.5mL)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)300mL盒(R1:3×75mL、R2:3×25mL；R1:5×45mL、R2:3×25mL；R1: | ||
| 适用范围： | 暂缺 | ||
| 采购信息： | 阿里巴巴采购平台 | ||
| 注册证编号 | 苏械注准20172400223 |
| 注册人名称 | 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 |
| 代理人名称 | 暂缺 |
| 代理人住所 | 暂缺 |
| 产品名称 | 前白蛋白检测试剂盒(比浊法) |
| 型号、规格 | 100mL盒(R1:1×75mL、R2:1×25mL；R1:2×37.5mL、R2:1×25mL；R1:3×25mL、 R2:2×12.5mL)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)300mL盒(R1:3×75mL、R2:3×25mL；R1:5×45mL、R2:3×25mL；R1: |
| 结构及组成 | 暂缺 |
| 适用范围 | 暂缺 |
| 其他内容 | 暂缺 |
| 备注 | 原注册证苏食药监械(准)字2013第2400333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 | 2017-02-24 |
| 有效期至 | 2022-02-23 |
| 附件 | 暂缺 |
| 产品标准 | 暂缺 |
| 变更日期 | 0000-00-00 |
| 邮编 | 暂缺 |
| 审批部门 | 暂缺 |
| 变更情况 | 暂缺 |
| 主要组成成分 | R1: 三羟甲基氨基甲烷缓冲液(Tris缓冲液)80mmolL pH7.5。 R2: 前白蛋白特异性血清≥1：4。注：不同批号之间的各组分不可以互换。 |
| 预期用途 | 本试剂用于人血清中前白蛋白含量的体外定量测定。 |
| 产品储存条件及有效期 | 暂缺 |