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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20172400283”基本信息
注册证编号沪械注准20172400283 [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
产品名称葡萄糖检测试剂盒(己糖激酶法)
管理类别第二类
型号规格R1:1×20ml、R2:1×5ml R1:1×60ml、R2:1×15ml R1:3×40ml、R2:1×30ml R1:3×60ml、R2:3×15ml R1:2×90ml、R2:3×15ml R1:3×80ml、R2:3×20ml R1:10×60ml、R2:10×15ml R1:2×300ml、R2:2×75ml R1:4×450ml、R2:3×150ml R1:6×66ml、R2:6×16ml R1:3×60ml、R2:1×45ml 700t(1×700t) 600t(2×300t) 2000t(1×2000t) 1050t(1×1050t) 2730t(1×2730t) 西门子测试数:1500测试/盒 R1:1×20ml、R2:1×5ml、校准品:1×1ml R1:1×60ml、R2:1×15ml、校准品:1×1ml R1:3×40ml、R2:1×30ml、校准品:1×1ml R1:3×60ml、R2:3×15ml、校准品:1×1ml R1:2×90ml、R2:3×15ml、校准品:1×1ml R1:3×80ml、R2:3×20ml、校准品:1×1ml R1:10×60ml、R2:10×15ml、校准品:1×1ml R1:2×300ml、R2:2×75ml、校准品:1×1ml R1:4×450ml、R2:3×150ml、校准品:1×1ml R1:6×66ml、R2:6×16ml、校准品:1×1ml R1:3×60ml、R2:1×45ml、校准品:1×1ml 700t(1×700t)、校准品:1×1ml 600t(2×300t)、校准品:1×1ml 2000t(1×2000t)、校准品:1×1ml 1050t(1×1050t)、校准品:1×1ml 2730t(1×2730t)、校准品:1×1ml 西门子测试数:1500测试/盒、校准品:1×1ml
结构及组成/主要组成成分R1:三乙醇胺、葡萄糖激酶、葡萄糖-6-磷酸脱氢酶、腺苷-5-三磷酸二钠、MgSO4、Proclin 300;R2:三乙醇胺、氧化烟酰胺腺苷二核苷磷酸、MgSO4、Proclin 300; 校准品 :Tris缓冲液、葡萄糖、稳定剂、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葡萄糖(GLU)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2022/4/18
生效日期2022/4/18
有效期至2027/4/17
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