| 注册证编号 | 沪械注准20172400276 [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 | 视黄醇结合蛋白检测试剂盒（乳胶增强免疫比浊法） |
| 管理类别 | 第二类 |
| 型号规格 | 1) R1:1×20ml、R2:1×7ml 2) R1:1×45ml、R2:1×15ml 3) R1:3×45ml、R2:3×15ml 4) R1:1×60ml、R2:1×20ml 5) R1:2×90ml、R2:4×15ml 6) R1:3×60ml、R2:3×20ml 7) R1:10×60ml、R2:10×20ml 8) R1:3×80ml、R2:4×20ml 9) R1:4×450ml、R2:4×150ml 10) R1:2×300ml、R2:2×100ml 11) R1:3×45ml、R2:1×45ml 12) 西门子测试数:1590测试/盒 13) R1:1×20ml、R2:1×7ml、校准品:5×0.5ml 14) R1:1×45ml、R2:1×15ml、校准品:5×0.5ml 15) R1:3×45ml、R2:3×15ml、校准品:5×0.5ml 16) R1:1×60ml、R2:1×20ml、校准品:5×0.5ml 17) R1:2×90ml、R2:4×15ml、校准品:5×0.5ml 18) R1:3×60ml、R2:3×20ml、校准品:5×0.5ml 19) R1:10×60ml、R2:10×20ml、校准品:5×0.5ml 20) R1:3×80ml、R2:4×20ml、校准品:5×0.5ml 21) R1:4×450ml、R2:4×150ml、校准品:5×0.5ml 22) R1:2×300ml、R2:2×100ml、校准品:5×0.5ml 23) R1:3×45ml、R2:1×45ml、校准品:5×0.5ml 24) 西门子测试数:1590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）、NaCl、甲基异噻唑酮（MIT）、正常兔血清、兔抗人IgM、Proclin 300；R2：甘氨酸、抗人RBP抗体致敏的乳胶颗粒、NaCl、Proclin 300；校准品：Tris、甘油、RBP抗原、Proclin300。 |
| 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中视黄醇结合蛋白的浓度，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 |
