甘胆酸（CG）校准品-京械注准20212400604-器械数据

产品名称：

甘胆酸（CG）校准品

注册人名称：

北京安图生物工程有限公司

注册(备案)号：

京械注准20212400604

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，水平1为缓冲液基质液体校准品，水平2-水平6为牛血清基质液体校准品。tttttttttttttt ttttttttttttttt成分ttttttttttttttt浓度ttttttttttttttttttt水平1ttttttttttttttt磷酸盐缓冲液ttttttttttttttt≥5mmol/Lttttttttt目标浓度：0mg/Lttttttttttttttttttt水平2ttttttttttttttt牛血清ttttttttt甘胆酸ttttttttttttttt≥5%ttttttttt目标浓度：2.5mg/Lttttttttttttttttttt水平3ttttttttttttttt牛血清ttttttttt甘胆酸ttttttttttttttt≥5%ttttttttt目标浓度：5mg/Lttttttttttttttttttt水平4ttttttttttttttt牛血清ttttttttt甘胆酸ttttttttttttttt≥5%ttttttttt目标浓度：15mg/Lttttttttttttttttttt水平5ttttttttttttttt牛血清ttttttttt甘胆酸ttttttttttttttt≥5%ttttttttt目标浓度：30mg/Lttttttttttttttttttt水平6ttttttttttttttt牛血清ttttttttt甘胆酸ttttttttttttttt≥5%ttttttttt目标浓度：70mg/Ltttttt t注：校准品靶值批特异，详见瓶签。

适用范围：

与该公司生产的试剂盒配套使用，用于甘胆酸（CG）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20212400604：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：

2℃～8℃避光保存，有效期为18个月。

管理类别：

第二类

备注：