| 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） |
|---|---|
| 结构及组成/主要组成成分 | R1：Tris、NaCl、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。产品有效期：12个月。附件：产品标准，产品说明书。 |
| 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。 |
| 型号规格 | 1) R1:1×20ml、R2:1×7ml2) R1:1×45ml、R2:1×15ml3) R1:3×45ml、R2:3×15ml4) R1:1×60ml、R2:1×20ml5) R1:2×90ml、R2:4×15ml6) R1:3×60ml、R2:3×20ml7) R1:10×60ml、R2:10×20ml8) R1:3×80ml、R2:4×20ml9) R1:4×450ml、R2:4×150ml10) R1:2×300ml、R2:2×100ml11) R1:3×45ml、R2:1×45ml12) 西门子测试数:1590测试/盒13) R1:1×20ml、R2:1×7ml、校准品:5×0.5ml14) R1:1×45ml、R2:1×15ml、校准品:5×0.5ml15) R1:3×45ml、R2:3×15ml、校准品:5×0.5ml16) R1:1×60ml、R2:1×20ml、校准品:5×0.5ml17) R1:2×90ml、R2:4×15ml、校准品:5×0.5ml18) R1:3×60ml、R2:3×20ml、校准品:5×0.5ml19) R1:10×60ml、R2:10×20ml、校准品:5×0.5ml20) R1:3×80ml、R2:4×20ml、校准品:5×0.5ml21) R1:4×450ml、R2:4×150ml、校准品:5×0.5ml22) R1:2×300ml、R2:2×100ml、校准品:5×0.5ml23) R1:3×45ml、R2:1×45ml、校准品:5×0.5ml24) 西门子测试数:1590测试/盒、校准品:5×0.5ml |
| 注册证编号 | 沪械注准20172400276 |
| 注册人名称 | 上海睿康生物科技有限公司 |
| 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 |
| 备注 | 原注册号：沪食药监械(准)字2013第2400577号 |
| 批准日期 | 2017-04-18 |
| 有效期至 | 2022-04-17 |
| 编码代号2018 | 6840IVD |
| 管理分类 | Ⅱ |
| 企业联系电话 | 021-60838199; 15112916626 |
| 网址 | 暂无权限 |
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