China NMPA legacy archive 国械注准20243400687Hepatitis B virus core IgM antibody test kit (chemiluminescence method)
- Device class
- Class III
- Model specifications
- 50 servings/box, 2×50 servings/box, 100 servings/box, 2×100 servings/box, 200 servings/box, 2×200 servings/box
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243400687
- Approval date
- April 11, 2024
- Expiry date
- April 10, 2029
- Province/Region
- Shanghai
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai
- Production address
- 上海市徐汇区桂平路 701 号
This product is used for the in vitro qualitative detection of hepatitis B virus core IgM antibody (Anti-HBc IgM) in human serum or plasma.
本产品用于体外定性检测人血清或血浆中的乙型肝炎病毒核心IgM抗体（Anti-HBc IgM）。
This kit contains Reagent 1 (R1), Reagent 2 (R2), Reagent 3 (R3), Reagent 4 (R4), Negative Mass Control, Positive Quality Control, and Calibration B. (Please refer to the product manual for details)
本试剂盒含有试剂1（R1）、试剂2（R2）、试剂3（R3）、试剂4（R4）、阴性质控、阳性质控、定标品B。（具体内容详见产品说明书）
Store at 2~8 °C, prohibit freezing, valid for 12 months.
2~8℃储存，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 Hepatitis B virus core IgM antibody test kit (chemiluminescence method), registration 国械注准20243400687. It does not establish current authorization or complete current product details.
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