Hepatitis 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/box50人份/盒、2×50人份/盒、100人份/盒、2×100人份/盒、200人份/盒、2×200人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243400687
- Approval date
- April 11, 2024
- Expiry date
- April 10, 2029
- Name
- Shanghai Kehua Bio-Engineering Co., Ltd.上海科华生物工程股份有限公司
- Province/Region
- Shanghai上海
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai上海市徐汇区钦州北路1189号
- 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
Access comprehensive regulatory information for Hepatitis B virus core IgM antibody test kit (chemiluminescence method) 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20243400687 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on April 11, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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.