同型半胱氨酸测定试剂盒(酶循环法)

国产有效注册第二类

产品名称：

同型半胱氨酸测定试剂盒(酶循环法)

注册人名称：

北京贝尔生物工程股份有限公司

京械注准20222400052

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）tttttttttttttttTris缓冲液ttttttttttttttt50mMtttttttttttttttttttL-丝氨酸ttttttttttttttt5mMtttttttttttttttttttLDHttttttttttttttt30KU/LtttttttttttttttttttNADHttttttttttttttt5mMtttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt试剂2（R2）tttttttttttttttPBS缓冲液ttttttttttttttt50mMtttttttttttttttttttCBSttttttttttttttt30KU/LtttttttttttttttttttCBLttttttttttttttt20KU/LtttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt校准品（选配）ttttttttttttttt人同型半胱氨酸tttttttttttttttS 20.0~40.0μmol/L，ttttttttt浓度批特异，见靶值单tttttttttttttttttttProclin300ttttttttttttttt1mL/Lttttttttttttttttttt质控品（选配）ttttttttttttttt人同型半胱氨酸tttttttttttttttQ1 7.0~12.0μmol/L，tttttttttQ2 15.0~30.0μmol/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和血浆样本中同型半胱氨酸（HCY）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 48mL×2/R2 12mL×2tttttttttttttttttttR1 48mL×1/R2 12mL×1tttttttttttttttttttR1 24mL×1/R2 6mL×1tttttttttttttttttttR1 8mL×1/R2 2mL×1ttttttttttttttttttt校准品(选配)ttttttttttttttt1mL×1ttttttttttttttttttt质控品(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）	同型半胱氨酸测定试剂盒(酶循环法)	京械注准20222400052	R1:48mL×2 R2:12mL×2	7200