潍坊三维生物工程集团有限公司
境内医疗器械（注册） — “鲁械注准20192400229”基本信息
| 注册证编号 | 鲁械注准20192400229 [查看相关产品信息] |
| 注册人名称 | 潍坊三维生物工程集团有限公司[查看公司信息] |
| 注册人住所 | 潍坊高新技术产业开发区桐荫街 |
| 生产地址 | 潍坊高新技术产业开发区志远路 |
| 产品名称 | 肌酐测定试剂(苦味酸法) |
| 管理类别 | 第二类 |
| 型号规格 | R1:1×80mL、R2:1×20mL；R1:4×20mL、R2:4×5 mL；R1:4×24mL、R2:4×6 mL； R1:2×80mL、R2:2×20mL；R1:4×40mL、R2:4×10mL；R1:3×60mL、R2:1×45mL：R1:5×40mL、R2:1×50mL；R1:4×50mL、R2:1×50mL；R1:4×60mL、R2:1×60mL；R1:5×80mL、R2:5×20mL；R1:6×70mL、R2:3×35mL；R1:1×100mL、R2:1×100mL；R1:2×30mL、R2:2×30mL；R1:4×25mL、R2:4×25mL；R1:2×60mL、R2:2×60mL；R1:3×40mL、R2:3×40mL；R1:3×50mL、R2:3×50mL；R1:1×80mL、R2:4×20mL；R1:2×40mL、R2:4×20mL；R1:2×25mL、R2:2×25mL；R1:8×25mL、R2:8×25mL；R1:4×30mL、R2:6×20mL；R1:4×20mL、R2:8×10mL；R1:2×40mL、R2:2×40mL；8×60T(R1:8×9.6mL、R2:8×9.6mL)。 |
| 结构及组成/主要组成成分 | 试剂1： NaOH（0.32mol/L）。 试剂2：苦味酸（35mmol/L）。 |
| 适用范围/预期用途 | 用于人血清或尿的肌酐含量的体外定量检测。 |
| 审批部门 | 山东省药品监督管理局 |
| 批准日期 | 2019/5/28 |
| 生效日期 | 2019/5/28 |
| 有效期至 | 2024/5/27 |
