β2-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：

注册人名称：

北京贝尔生物工程股份有限公司

京械注准20212400224

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ttttttttttttttttttt主要成分ttttttttttttttttttt浓度ttttttttttttttttttttttttt试剂1（R1）tttttttttttttttttttPBS缓冲液ttttttttttttttttttt50mMtttttttttttttttttttttttttProclin300ttttttttttttttttttt1mL/Lttttttttttttttttttttttttt试剂2（R2）ttttttttttttttttttt标记β2-微球蛋白多抗的胶乳溶液ttttttttttttttttttt0.25%tttttttttttttttttttttttttProclin300ttttttttttttttttttt1mL/Lttttttttttttttttttttttttt校准品（血液，选配）ttttttttttttttttttt人β2-微球蛋白抗原tttttttttttttttttttS1 0.00mg/L，tttttttttttS2 1.00~2.50mg/L，tttttttttttS3 3.00~4.50mg/L，tttttttttttS4 6.00~9.00mg/L，ttttttttttt S5 12.00~16.00mg/L，tttttttttttS6 24.00~30.00mg/Lttttttttttt浓度批特异，见靶值单ttttttttttttttttttttttttt校准品（尿液，选配）tttttttttttttttttttUS1 0.00mg/L，tttttttttttUS2 0.10~0.25mg/L，tttttttttttUS3 0.30~0.45mg/L，tttttttttttUS4 0.60~0.90mg/L，tttttttttttUS5 1.20~1.60mg/L，ttttttttttt US6 2.40~3.00mg/Lttttttttttt浓度批特异，见靶值单tttttttttttttttttttttttttProclin300ttttttttttttttttttt1mL/Lttttttttttttttttttttttttt质控品（血液，选配）ttttttttttttttttttt人β2-微球蛋白抗原tttttttttttttttttttQ1 0.80~2.50mg/L，tttttttttttQ2 4.00~8.00mg/Lttttttttttt浓度批特异，见靶值单ttttttttttttttttttttttttt质控品（尿液，选配）ttttttttttttttttttt UQ1 0.20~0.50mg/L，tttttttttttUQ2 0.60~1.00mg/Lttttttttttt浓度批特异，见靶值单tttttttttttttttttttttttttProclin300ttttttttttttttttttt1mL/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β2-微球蛋白的含量。

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（血液，选配）ttttttttttttttt0.5mL×6ttttttttttttttttttt校准品（尿液，选配）ttttttttttttttt1mL×6ttttttttttttttttttt质控品（血液，选配）ttttttttttttttt0.5mL×2ttttttttttttttttttt质控品（尿液，选配）ttttttttttttttt1mL×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）	β2-微球蛋白测定试剂盒（胶乳免疫比浊法）	京械注准20212400224	R1 45ml2,R2 15ml2	12000