| 注册证编号 | 沪械注准20172400240 [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 | 载脂蛋白A1检测试剂盒（免疫比浊法） |
| 管理类别 | 第二类 |
| 型号规格 | 1) R1:1×20ml、R2:1×7ml; 2) R1:1×30ml、R2:1×10ml 3) R1:3×45ml、R2:3×15ml; 4) R1:1×45ml、R2:1×15ml; 5) R1:2×90ml、R2:4×15ml 6) R1:1×60ml、R2:1×20ml; 7) R1:10×60ml、R2:10×20ml; 8) R1:3×60ml、R2:3×20ml 9) R1:4×450ml、R2:4×150ml; 10) R1:3×80ml、R2:4×20ml; 11) R1:2×300ml、R2:2×100ml; 12) R1:6×19ml、R2:6×5ml; 13) 西门子测试数:1680测试/盒; 14) R1:1×20ml、R2:1×7ml、校准品:1×1ml; 15) R1:1×30ml、R2:1×10ml、校准品:1×1ml 16) R1:3×45ml、R2:3×15ml、校准品:1×1ml; 17) R1:1×45ml、R2:1×15ml、校准品:1×1ml; 18) R1:2×90ml、R2:4×15ml、校准品:1×1ml; 19) R1:1×60ml、R2:1×20ml、校准品:1×1ml; 20) R1:10×60ml、R2:10×20ml、校准品:1×1ml; 21) R1:3×60ml、R2:3×20ml、校准品:1×1ml; 22) R1:4×450ml、R2:4×150ml、校准品:1×1ml; 23) R1:3×80ml、R2:4×20ml、校准品:1×1ml; 24) R1:2×300ml、R2:2×100ml、校准品:1×1ml; 25) R1:6×19ml、R2:6×5ml、校准品:1×1ml; 26) 西门子测试数:1680测试/盒、校准品:1×1ml |
| 结构及组成/主要组成成分 | R1：Tris 缓冲液（pH7.4）、聚乙二醇6000、NaCl、防腐剂；R2：羊抗人APOA抗血清、Tris缓冲液（pH7.4）、NaCl、防腐剂；校准品：Tris缓冲液（pH7.4）、APOA1抗原、氯化钠、甘油、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载脂蛋白A1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 |
