China NMPA legacy archive 国械注准20253400208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）
- Device class
- Class III
- Model specifications
- 10 servings/box, 2×10 servings/box, 3×10 servings/box, 4×10 servings/box, 25 servings/box, 2×25 servings/box, 3×25 servings/box, 4×25 servings/box, 50 servings/box, 2×50 servings/box, 3×50 servings/box, 4×50 servings/box, 75 servings/box, 2×75 servings/box, 3×75 servings/box, 100 servings/box, 2×100 servings/box, 150 persons/box, 200 servings/box.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20253400208
- Approval date
- January 20, 2025
- Expiry date
- January 19, 2030
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- Production address
- 南京市六合区沿江工业开发区博富路9号；南京市江北新区科丰路6号
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。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations 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）, registration 国械注准20253400208. It does not establish current authorization or complete current product details.
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