载脂蛋白A1检测试剂盒（免疫比浊法）

沪械注准20172400240

沪械注准20172400240

上海市闵行区三鲁公路3279号1幢1号楼3层、4层

上海市闵行区三鲁公路3279号1幢1号楼3层、4层

载脂蛋白A1检测试剂盒（免疫比浊法）

第二类

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

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。

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。

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上海市药品监督管理局

2022-03-31

2027-03-30

注册人住所、生产地址由“上海市闵行区联航路1588号1幢软件孵化大楼1#楼301、302室”变更为“上海市闵行区三鲁公路3279号1幢1号楼3层、4层”。;本文件与“沪械注准20172400240”注册证共同使用。;2017-09-05