胃蛋白酶原Ⅱ测定试剂盒（胶乳免疫比浊法）

国产有效注册第二类

产品名称：

注册人名称：

北京贝尔生物工程股份有限公司

京械注准20222400049

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ttttttttttttttt50mMtttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt试剂2（R2）ttttttttttttttt标记胃蛋白酶原Ⅱ抗体的胶乳溶液ttttttttttttttt0.2%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校准品(选配)ttttttttttttttt人胃蛋白酶原Ⅱ抗原tttttttttttttttS1 0.00ng/mL，tttttttttS2 3.00~8.00ng/mL，tttttttttS3 9.00~18.00ng/mL，tttttttttS4 20.00~30.0ng/mL，tttttttttS5 40.00~60.0ng/mL，tttttttttS6 80.00~120.0ng/mL，ttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt质控品（选配）ttttttttttttttt人胃蛋白酶原Ⅱ抗原tttttttttttttttQ1 8.00~20.00ng/mL，tttttttttQ2 25.00~50.00ng/mL，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样本中胃蛋白酶原Ⅱ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×6ttttttttttttttttttt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）	胃蛋白酶原Ⅱ测定试剂盒（胶乳免疫比浊法）	京械注准20222400049	R1 45ml2,R2 15ml2	12000