| 注册证号： | 京药监械(准)字2012第2400256号 | 分类目录： | 体外诊断试剂 |
| 注册公司： | 北京九强生物技术股份有限公司 | 代理公司： | 暂缺 |
| 规格型号： | R1:2×20ml、R2:1×20ml；R1:2×50ml、R2:1×50m；R1:4×50ml、R2:2×50m；R1:2×15ml、R2:2×15ml；R1:2×50ml、R2:2×50ml；R1:3×20ml、R2:1×20ml；R1:3×60ml、R2:3×20ml；R1:1×60ml、R2:1×20ml；R1:3×20ml、R2:1×15ml；R1:3×60ml、R2:3×15ml；R1:3×20ml、R2:1 | ||
| 适用范围： | 暂缺 | ||
| 采购信息： | 阿里巴巴采购平台 | ||
| 注册证编号 | 京药监械(准)字2012第2400256号 |
| 注册人名称 | 北京九强生物技术股份有限公司 |
| 注册人住所 | 北京市海淀区花园东路15号旷怡大厦5层 |
| 生产地址 | 北京市怀柔区雁栖经济开发区雁栖北二街15号 |
| 代理人名称 | 暂缺 |
| 代理人住所 | 暂缺 |
| 产品名称 | 肌钙蛋白I测定试剂盒(胶乳增强免疫比浊法) |
| 型号、规格 | R1:2×20ml、R2:1×20ml；R1:2×50ml、R2:1×50m；R1:4×50ml、R2:2×50m；R1:2×15ml、R2:2×15ml；R1:2×50ml、R2:2×50ml；R1:3×20ml、R2:1×20ml；R1:3×60ml、R2:3×20ml；R1:1×60ml、R2:1×20ml；R1:3×20ml、R2:1×15ml；R1:3×60ml、R2:3×15ml；R1:3×20ml、R2:1 |
| 结构及组成 | 暂缺 |
| 适用范围 | 暂缺 |
| 其他内容 | 暂缺 |
| 备注 | 本文件与“京药监械(准)字2012第2400256号”注册证共同使用。 |
| 批准日期 | 2012-03-02 |
| 有效期至 | 2016-03-05 |
| 附件 | 暂缺 |
| 产品标准 | 暂缺 |
| 变更日期 | 2016-03-07 |
| 邮编 | 暂缺 |
| 审批部门 | 暂缺 |
| 变更情况 | 规格型号：R1:2X20 ml、R2:1X20 ml；R1:2X50ml、R2: 1X50m；R1: 4X50ml、R2: 2X50m；R1:2X15ml、R2: 2X15ml；R1: 2X50ml、R2: 2X50ml；R1:3X20ml、R2:1X20 ml；R1:3X60 ml、R2:3X20 ml；R1:1X60 ml、R2:1X20 ml；R1:3X20 ml、R2:1X15 ml；R1:3X60 ml、R2:3X15 ml；R1:3X20 ml、R2:1X12 ml；R1:2X50 ml、 |
| 主要组成成分 | R1：甘氨酸缓冲液；R2：乳胶颗粒超敏化的肌钙蛋白I抗体液；校准品（液体，人血清基质）：肌钙蛋白I；质控品（液体，人血清基质）：肌钙蛋白I |
| 预期用途 | 暂缺 |
| 产品储存条件及有效期 | 暂缺 |