总胆汁酸测定试剂盒(酶循环法)

国产有效注册第二类

产品名称：

总胆汁酸测定试剂盒(酶循环法)

注册人名称：

北京贝尔生物工程股份有限公司

京械注准20222400055

注册人住所：

北京市大兴区黄村镇芦城工业开发区创新路99号

批准(备案)日期：

2022-01-17

有效期至：

2027-01-16

结构及组成：

类型ttttttttttttttt主要成分ttttttttttttttt浓度ttttttttttttttttttt试剂1（R1）tttttttttttttttPBS缓冲液ttttttttttttttt50mMtttttttttttttttttttThio-NAD+ttttttttttttttt900mg/LtttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt试剂2（R2）tttttttttttttttPBS缓冲液ttttttttttttttt50mMtttttttttttttttttttThio-NADHttttttttttttttt5.0g/Lttttttttttttttttttt3α-HSDttttttttttttttt10KU/LtttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校准品（选配）ttttttttttttttt人总胆汁酸tttttttttttttttS 45.0~70.0μmol/L，ttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt质控品（选配）ttttttttttttttt人总胆汁酸tttttttttttttttQ1 20.0~40.0μmol/L，tttttttttQ2 45.0~80.0μmol/L，ttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/L

适用范围：

本产品用于体外定量测定人血清和血浆中总胆汁酸（TBA）的含量。

代理公司：

代理公司地址：

变更情况：

生产地址：

北京市大兴区黄村镇芦城工业开发区创新路99号

型号规格：

组分ttttttttttttttt规格ttttttttttttttttttt试剂tttttttttttttttR1 45mL×2/R2 15mL×2tttttttttttttttttttR1 45mL×1/R2 15mL×1tttttttttttttttttttR1 22.5mL×1/R2 7.5mL×1tttttttttttttttttttR1 7.5mL×1/R2 2.5mL×1ttttttttttttttttttt校准品(选配)ttttttttttttttt0.5mL×1ttttttttttttttttttt质控品(选配)ttttttttttttttt0.5mL×2

产品储存条件及有效期：

试剂盒密封保存于2～8℃，有效期12个月

管理类别：

第二类

备注：

挂网信息

数据来源	注册备案名	注册证编号	型号规格	挂网报价
湖南医用耗材拟挂产品公示（第五十三批）	总胆汁酸测定试剂盒(酶循环法)	京械注准20222400055	R1 45ml2,R2 15ml2	7200