肌钙蛋白I(cTnI)校准品

国产有效注册第二类

产品名称：

肌钙蛋白I(cTnI)校准品

注册人名称：

北京安图生物工程有限公司

京械注准20212400627

注册人住所：

北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)

批准(备案)日期：

2021-11-25

有效期至：

2026-11-24

结构及组成：

6水平，牛血清基质液体校准品。tttttttttttttt ttttttttttttttt成分ttttttttttttttt浓度ttttttttttttttttttt水平1ttttttttttttttt牛血清ttttttttt该校准品为牛血清基质液体校准品ttttttttttttttt≥20%ttttttttt目标浓度：0ng/mLttttttttttttttttttt水平2ttttttttttttttt牛血清ttttttttt肌钙蛋白Ittttttttt该校准品为牛血清基质液体校准品ttttttttttttttt≥20%ttttttttt目标浓度：1ng/mLttttttttttttttttttt水平3ttttttttttttttt牛血清ttttttttt肌钙蛋白Ittttttttt该校准品为牛血清基质液体校准品ttttttttttttttt≥20%ttttttttt目标浓度：1.5ng/mLttttttttttttttttttt水平4ttttttttttttttt牛血清ttttttttt肌钙蛋白Ittttttttt该校准品为牛血清基质液体校准品ttttttttttttttt≥20%ttttttttt目标浓度：2.4ng/mLttttttttttttttttttt水平5ttttttttttttttt牛血清ttttttttt肌钙蛋白Ittttttttt该校准品为牛血清基质液体校准品ttttttttttttttt≥20%ttttttttt目标浓度：4.5ng/mLttttttttttttttttttt水平6ttttttttttttttt牛血清ttttttttt肌钙蛋白Ittttttttt该校准品为牛血清基质液体校准品ttttttttttttttt≥20%ttttttttt目标浓度：11ng/mLtttttt 注：校准品靶值批特异，详见瓶签。

适用范围：

与本公司生产的试剂盒配套使用，用于肌钙蛋白I（cTnI）检测系统的校准。

代理公司：

代理公司地址：

变更情况：

t生产地址：“京械注准20212400627：北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)”变更为“北京市顺义区北务镇民泰路13号院17号楼、18号楼、24号楼(科技创新功能区)”。

(批准日期：20220106)

生产地址：

北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)

型号规格：

1mL×6

产品储存条件及有效期：

该产品在2℃～8℃避光保存，有效期为12

管理类别：

第二类

备注：