| 注册证编号 | 苏械注准20172400229 [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 | 镁检测试剂盒（终点法） |
| 管理类别 | 第二类 |
| 型号规格 | 100mL/盒(R1:1×91mL、R2:1×18mL；R1:2×45.5mL、R2:1×18mL；R1:3×30.3mL、R2:1×18mL；R1:4×22.8mL、R2:1×15mL)200mL/盒(R1:2×91mL、R2:2×18mL；R1:4×45.5mL、R2:2×18mL；R1:5×36.4mL、R2:2×18mL；R1:2×91mL、R2:1×36mL；R1:8×22.8mL、R2:2×15mL)300mL/盒(R1:3×91mL、R2:2×18mL；R1:4×68.2mL、R2:2×18mL；R1:6×45.5mL、R2:2×18mL；R1:6×45.5mL、R2:1×36mL；R1:8×34.1mL、R2:2×18mL；R1:5×54.6mL、R2:2×18mL） |
| 结构及组成/主要组成成分 | 试剂1：钙镁试剂（Calmagite）0.006%，叠氮化钠0.1%，聚乙烯吡咯烷酮-K30（PVP K30）0.03 %。试剂2: 2-乙氨乙醇6.0 %。 |
| 适用范围/预期用途 | 用于人血清或血浆中镁浓度的体外定量测定。临床上用于镁代谢紊乱的辅助诊断。 |
| 审批部门 | 江苏省药品监督管理局 |
| 批准日期 | 2021/12/7 |
| 生效日期 | 2021/12/7 |
| 有效期至 | 2027/2/23 |
