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肌红蛋白测定试剂盒（胶乳免疫比浊法）

国产有效注册第二类

产品名称：

肌红蛋白测定试剂盒（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20222400051

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标记肌红蛋白抗体的胶乳溶液ttttttttttttttt0.2%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校准品（选配）ttttttttttttttt人肌红蛋白抗原tttttttttttttttS1 0.0ng/mL，tttttttttS2 80.0~120.0ng/mL，tttttttttS3 160.0~240.0ng/mL，tttttttttS4 320.0~480.0ng/mL，tttttttttS5 600.00~900.0ng/mL，ttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt质控品（选配）ttttttttttttttt人肌红蛋白抗原tttttttttttttttQ1 80.0~150.0ng/mL，tttttttttQ2 200.0~400.0ng/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肌红蛋白的含量。

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×5（5水平、冻干）ttttttttttttttttttt质控品（选配）ttttttttttttttt0.5mL×2（2水平、冻干）

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