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同型半胱氨酸（HCY）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（HCY）测定试剂盒（酶循环法）

注册人名称：

北京安图生物工程有限公司

京械注准20222400291

注册人住所：

北京市顺义区北务镇民泰路13号院17号楼、18号楼(科技创新功能区)

批准(备案)日期：

2022-07-22

有效期至：

2027-07-21

结构及组成：

成分ttttttttttttttt浓度ttttttttttttttttttt试剂1tttttttttR1tttttttttttttttNADHtttttttttDL-丝氨酸ttttttttttttttt≥0.1mmol/Lttttttttt≥20mmol/Lttttttttttttttttttt试剂2tttttttttR2ttttttttttttttt胱硫醚-β-合成酶ttttttttt胱硫醚-β-裂解酶ttttttttttttttt≥2KU/Lttttttttt≥2KU/Lttttttttttttttttttt校准品ttttttttt(选配)ttttttttttttttt2水平，液体ttttttttt磷酸盐缓冲液(0.1-10mmol/L，pH≤6.0）tttttttttDL-同型半胱氨酸ttttttttttttttt目标浓度：0.0μmol/L、30.0μmol/Lttttttttttttttttttt质控品ttttttttt低值ttttttttt(选配)ttttttttttttttt液体ttttttttt磷酸盐缓冲液(0.1-10mmol/L，pH≤6.0）tttttttttDL-同型半胱氨酸ttttttttttttttt目标浓度范围：（8-20）μmol/Lttttttttttttttttttt质控品ttttttttt高值ttttttttt(选配)ttttttttttttttt液体ttttttttt磷酸盐缓冲液(0.1-10mmol/L，pH≤6.0）tttttttttDL-同型半胱氨酸ttttttttttttttt目标浓度范围：（20-40）μmol/Ltttttt校准品靶值、质控品质控范围具有批特异性，详见瓶签。

适用范围：

用于体外定量检测人血清中同型半胱氨酸的浓度。

生产地址：

北京市顺义区北务镇民泰路13号院17号楼、18号楼、24号楼（科技创新功能区）

型号规格：

试剂1:90mL×4，试剂2:90mL×1；t试剂1:90mL×4，试剂2:45mL×2；t试剂1:60mL×5，试剂2:15mL×5；t试剂1:60mL×2，试剂2:15mL×2；t试剂1:60mL×1，试剂2:15mL×1；t试剂1:60mL×4，试剂2:60mL×1；t试剂1:60mL×4，试剂2:30mL×2；t试剂1:40mL×2，试剂2:10mL×2；t试剂1:40mL×1，试剂2:10mL×1；t试剂1:16mL×1，试剂2:4mL×1；t试剂1:280mL×1，试剂2:70mL×1；t试剂1:4000mL×1，试剂2:1000mL×1；t400人份(试剂1:64mL×1，试剂2:16mL×1)；t1800人份(试剂1:288mL×1，试剂2:72mL×1)；t校准品(选配) :1mL×1（2水平）；t质控品低值(选配) :1mL×1；质控品高值（选配）:1mL×1。

产品储存条件及有效期：

2℃～8℃密封避光贮存，有效期为12个月

管理类别：

第二类