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上海睿康生物科技有限公司

境内医疗器械(注册) — “沪械注准20172400246”基本信息
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
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