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 |