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α1-微球蛋白测定试剂盒（胶乳免疫比浊法）

国产有效注册第二类

产品名称：

α1-微球蛋白测定试剂盒（胶乳免疫比浊法）

注册人名称：

北京贝尔生物工程股份有限公司

京械注准20212400228

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：

2021-05-10

有效期至：

2026-05-09

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α1-微球蛋白多抗的胶乳溶液ttttttttttttttt0.3%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校准品（选配）ttttttttttttttt人α1-微球蛋白抗原tttttttttttttttS1 0.00mg/L，tttttttttS2 8.00~15.00mg/L，tttttttttS3 20.00~30.00mg/L，tttttttttS4 40.00~60.00mg/L，tttttttttS5 80.00~120.00mg/L，tttttttttS6 150.00~200.00mg/Lttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt质控品（选配）ttttttttttttttt人α1-微球蛋白抗原tttttttttttttttQ1 10.00~30.00mg/L，tttttttttQ2 40.00~80.00mg/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、血浆和尿液样本中α1-微球蛋白的含量。

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