| 注册证编号 | 苏械注准20172400174 [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 | 同型半胱氨酸检测试剂盒（循环酶法） |
| 管理类别 | 第二类 |
| 型号规格 | 55mL/盒 (R1:1×50mL、R2:1×5mL；R1:2×25mL、R2:1×5mL)、110mL/盒((R1:2×50mL、R2:1×10mL；R1:4×25mL、R2:1×10mL)、165mL/盒(R1:3×50mL、R2:1×15mL；R1:3×50mL、R2:2×7.5mL；R1:6×25mL、R2:1×15mL；R1:6×25mL、R2:2×7.5mL；R1:4×37.5mL、R2:1×15mL；R1:4×37.5mL、R2:2×7.5mL）、220mL/盒(R1:4×50mL、R2:1×20mL；R1:4×50mL、R2:2×10mL；R1:5×40mL、R2:1×20mL； R1:5×40mL、R2:2×10mL）、275mL/盒(R1:5×50mL、R2:1×25mL；R1:5×50mL、R2:2×12.5mL；R1:4×62.5mL、R2:1×25mL；R1:4×62.5mL、R2:2×12.5mL）、165T；330T；495T；660T |
| 结构及组成/主要组成成分 | 试剂1: 腺苷甲硫氨酸（SAM）0.1mmol/L；还原型辅酶Ⅰ（NADH）0.2mmol/L；三（2羧乙基）膦氯化氢（TCEP）0.5mmol/L。 试剂2: α-酮戊二酸5.0mmol/L；谷氨酸脱氢酶(GLDH) 10KU/L；S-腺苷同型半胱氨酸水解酶（SAHase）3.0KU/L；同型半胱氨酸甲基转移酶（HMTase）5.0KU/L；腺苷脱氨酶(ADA) 5.0KU/L。 |
| 适用范围/预期用途 | 用于人血清中的同型半胱氨酸体外定量测定。 |
| 审批部门 | 江苏省药品监督管理局 |
| 批准日期 | 2021/9/26 |
| 生效日期 | 2021/9/26 |
| 有效期至 | 2026/9/25 |
