Hepatitis B virus pre-S1 antigen detection test kit (enzyme-linked immunosorbent assay)
- Device class
- Class III
- Model specifications
- 48 servings/box, 96 servings/box48人份/盒、96人份/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20173401257
- Approval date
- July 08, 2022
- Expiry date
- July 07, 2027
- Name
- Shanghai Fosun LONG March MEDICAL Science Co., Ltd.复星诊断科技（上海）有限公司
- Province/Region
- Shanghai上海
- Address
- 830 Chengyin Road, Baoshan District, Shanghai上海市宝山区城银路830号
- Production address
- 上海市宝山区城银路830号
This product is used for in vitro qualitative detection of hepatitis B virus pre-S1 antigen in human serum samples.
本产品用于体外定性检测人血清样本中的乙型肝炎病毒前S1抗原。
Coated antibody microplate, enzyme-labeled antibody working solution, positive control of hepatitis B virus S1 antigen, negative control of hepatitis B virus pre-S1 antigen, concentrated washing solution (diluted 20 times in time), TMB chromogenic solution A, TMB chromogenic solution B, and stop solution. (Please refer to the product manual for details)
包被抗体微孔板、酶标记抗体工作液、乙型肝炎病毒前S1抗原阳性对照、乙型肝炎病毒前S1抗原阴性对照、浓缩洗涤液（用时20倍稀释）、TMB显色液A、TMB显色液B、终止液。（具体内容详见产品说明书）
Store at 2~8°C in the dark, valid for 12 months.
2～8℃避光保存，有效期12个月。
- Changes
- 2021-06-18 “注册人名称:上海复星长征医学科学有限公司”变更为“注册人名称:复星诊断科技（上海）有限公司”。 2022-05-19 为符合国家参考品，修改产品技术要求和产品说明书。具体详见附件。请注册人自行修改产品说明书和产品技术要求中的相关内容。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Hepatitis B virus pre-S1 antigen detection test kit (enzyme-linked immunosorbent assay) 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20173401257 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on July 08, 2022.
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.