| 注册证号： | 苏食药监械(准)字2013第2400335号 | 分类目录： | 体外诊断试剂 |
| 注册公司： | 东软威特曼生物科技（南京）有限公司 | 代理公司： | 暂缺 |
| 规格型号： | 100ml/盒(R1:1×75ml、R2:1×25ml；R1:2×37.5ml、R2:1×25ml；R1:3×25ml、R2:2×12.5ml)200ml/盒(R1:2×75ml、R2:2×25ml；R1:3×50ml、R2:1×50mlR1:4×37.5ml、R2:2×25ml；R1:3×50ml、R2:2×25ml；R1:2×75ml、R2:1×50ml；R1:6×25ml、R2:4×12.5ml)300ml/盒(R1:3×75ml、R2:3×25ml；R1:5×45ml、R2:3×25ml；R1:5 | ||
| 适用范围： | 用于人血清或血浆中总胆汁酸含量的体外定量测定。 | ||
| 采购信息： | 阿里巴巴采购平台 | ||
| 注册证编号 | 苏食药监械(准)字2013第2400335号 |
| 注册人名称 | 威特曼生物科技(南京)有限公司 |
| 注册人住所 | 暂缺 |
| 生产地址 | 南京市雨花台区西善桥南路108号2号楼 |
| 代理人名称 | 暂缺 |
| 代理人住所 | 暂缺 |
| 产品名称 | 总胆汁酸检测试剂盒(速率法) |
| 型号、规格 | 100ml/盒(R1:1×75ml、R2:1×25ml；R1:2×37.5ml、R2:1×25ml；R1:3×25ml、R2:2×12.5ml)200ml/盒(R1:2×75ml、R2:2×25ml；R1:3×50ml、R2:1×50mlR1:4×37.5ml、R2:2×25ml；R1:3×50ml、R2:2×25ml；R1:2×75ml、R2:1×50ml；R1:6×25ml、R2:4×12.5ml)300ml/盒(R1:3×75ml、R2:3×25ml；R1:5×45ml、R2:3×25ml；R1:5 |
| 结构及组成 | 总胆汁酸检测试剂盒（速率法）由试剂1Good’s缓冲液120mmol/L和试剂2（3α-羟基类固醇脱氢酶(3α-HSD) 12.5KU/L、硫代辅酶（Thio-NAD）6.1g/L）组成。基本参数：试剂空白吸光度≤0.8 OD值；空白吸光度变化率≤0.03 OD；线性范围2-180umol/L,r≥0.99；批内精密度CV≤3%；批间差≤6%；准确度：相对偏差应在±10%之内。 |
| 适用范围 | 用于人血清或血浆中总胆汁酸含量的体外定量测定。 |
| 其他内容 | 暂缺 |
| 备注 | 暂缺 |
| 批准日期 | 2013-03-22 |
| 有效期至 | 2017-03-21 |
| 附件 | 暂缺 |
| 产品标准 | YZB/苏0401-2013总胆汁酸检测试剂盒（速率法） |
| 变更日期 | 0000-00-00 |
| 邮编 | 暂缺 |
| 审批部门 | 暂缺 |
| 变更情况 | 暂缺 |
| 主要组成成分 | 暂缺 |
| 预期用途 | 暂缺 |
| 产品储存条件及有效期 | 暂缺 |