乙型肝炎病毒核心抗体定量检测试剂盒（化学发光免疫分析法） - NMPA Registration 国械注准20253400208
Access comprehensive regulatory information for 乙型肝炎病毒核心抗体定量检测试剂盒（化学发光免疫分析法） in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253400208 and owned by Getein Biotech, Inc.. The device was approved on January 20, 2025.
This page provides complete registration details including registrant information, province location (Jiangsu), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
本试剂盒用于临床体外定量检测人血清或血浆中的乙型肝炎病毒核心抗体（Anti-HBc）的含量。
L1:乙型肝炎病毒核心抗原（重组抗原，大肠杆菌表达）包被的磁性微粒；含100mM Tris 和0.1% ProClin300防腐剂。L:校准品L（0.8~1.2 IU/mL），乙型肝炎病毒核心抗体（小鼠单克隆），含2%牛血清白蛋白BSA和0.1% ProClin300防腐剂的0.02M磷酸盐缓冲液， PH=7.4±0.2）。H：校准品H（12~18 IU/mL），乙型肝炎病毒核心抗体（小鼠单克隆），含2%牛血清白蛋白BSA和0.1% ProClin300防腐剂的0.02M磷酸盐缓冲液， PH=7.4±0.2）。L3：吖啶酯标记的乙型肝炎病毒核心抗体（小鼠单克隆），0.038ug/ml—0.094ug/ml，50mM吗啉乙磺酸缓冲液（pH=6.0±0.1）；含0.1% 叠氮钠防腐剂。L4：项目稀释液：50mM吗啉乙磺酸缓冲液（pH=6.0±0.1），含0.1% 叠氮钠防腐剂。（具体内容详见说明书）
Store at 2~8 °C in the dark, prohibit freezing, valid for 12 months.
2～8℃避光保存，禁止冷冻，有效期12个月。