| 注册证编号 | 沪械注准20172400246 [查看相关产品信息] |
| 注册人名称 | 上海睿康生物科技有限公司[查看公司信息] |
| 注册人住所 | 上海市闵行区三鲁公路3279号1幢1号楼3层、4层 |
| 生产地址 | 上海市闵行区三鲁公路3279号1幢1号楼3层、4层 |
| 产品名称 | 脂蛋白a检测试剂盒（乳胶增强免疫比浊法） |
| 管理类别 | 第二类 |
| 型号规格 | 1) R1:1×20ml、R2:1×5ml 2) R1:1×60ml、R2:1×15ml 3) R1:3×40ml、R2:1×30ml 4) R1:3×60ml、R2:3×15ml 5) R1:2×90ml、R2:3×15ml 6) R1:3×80ml、R2:3×20ml 7) R1:10×60ml、R2:10×15ml 8) R1:2×300ml、R2:2×75ml 9) R1:4×450ml、R2:3×150ml 10) 西门子测试数:1650测试/盒 11) R1:1×20ml、R2:1×5ml、校准品:5×0.5ml 12) R1:1×60ml、R2:1×15ml、校准品:5×0.5ml 13) R1:3×40ml、R2:1×30ml、校准品:5×0.5ml 14) R1:3×60ml、R2:3×15ml、校准品:5×0.5ml 15) R1:2×90ml、R2:3×15ml、校准品:5×0.5ml 16) R1:3×80ml、R2:3×20ml、校准品:5×0.5ml 17) R1:10×60ml、R2:10×15ml、校准品:5×0.5ml 18) R1:2×300ml、R2:2×75ml、校准品:5×0.5ml 19) R1:4×450ml、R2:3×150ml、校准品:5×0.5ml 20) 西门子测试数:1650测试/盒、校准品:5×0.5ml |
| 结构及组成/主要组成成分 | R1：三羟甲基氨基甲烷（Tris）、正常兔血清、兔抗人IgM、Proclin 300、NaCl、甲基异噻唑酮（MIT）；R2：甘氨酸、NaCl、抗人Lp（a）抗体致敏的乳胶颗粒、Proclin 300；校准品：Tris、甘油、氯化钠、Lp（a）抗原、防腐剂 |
| 适用范围/预期用途 | 供医疗机构用于体外定量检测人血清或血浆样本中的脂蛋白a的含量，作辅助诊断用。 |
| 审批部门 | 上海市药品监督管理局 |
| 批准日期 | 2022/3/31 |
| 生效日期 | 2022/3/31 |
| 有效期至 | 2027/3/30 |
