低密度脂蛋白胆固醇测定试剂盒(直接清除法)

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20222400048

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ttttttttttttttt50mMttttttttttttttttttt聚阴离子化合物ttttttttttttttt0.5mMtttttttttttttttttttTOOSttttttttttttttt1mMttttttttttttttttttt4-AAPttttttttttttttt0.5mMttttttttttttttttttt胆固醇酯酶ttttttttttttttt1KU/Lttttttttttttttttttt胆固醇氧化酶ttttttttttttttt500U/Lttttttttttttttttttt表面活性剂ttttttttttttttt0.1%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt试剂2（R2）tttttttttttttttPBS缓冲液ttttttttttttttt50mMttttttttttttttttttt过氧化物酶ttttttttttttttt3KU/Lttttttttttttttttttt表面活性剂ttttttttttttttt0.1%tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校准品（选配）ttttttttttttttt人低密度脂蛋白胆固醇tttttttttttttttS 2.00~4.00mmol/L，ttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt质控品（选配）ttttttttttttttt人低密度脂蛋白胆固醇tttttttttttttttQ1 1.50~3.00mmol/L，tttttttttQ2 3.50~6.00mmol/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样本中低密度脂蛋白胆固醇（LDL-C）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)ttttttttttttttt1mL×1（单水平、冻干）ttttttttttttttttttt质控品(选配)ttttttttttttttt1mL×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

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）	低密度脂蛋白胆固醇测定试剂盒(直接清除法)	京械注准20222400048	R1 45ml2,R2 15ml2	7200