Hepatitis B virus e antibody (HBeAb) assay kit (Chemiluminescent magnetic particle method)
- Device class
- Class III
- Model specifications
- 100 tests/box, 50 tests/box100测试/盒、50测试/盒
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20173401374
- Approval date
- July 18, 2022
- Expiry date
- August 29, 2027
- Name
- Beijing Leadman Biochemistry Co., Ltd.北京利德曼生化股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 5 Xinghai Road, Beijing Economic and Technological Development Zone, Beijing北京市北京经济技术开发区兴海路5号
- Production address
- 北京市北京经济技术开发区兴海路5号1幢2层、6层、B1层、2幢
This product is used for in vitro qualitative detection of hepatitis B virus e antibody (HBeAb) in human serum or plasma.
本产品用于体外定性检测人体血清或血浆中的乙型肝炎病毒e抗体（HBeAb）。
The kit consists of Reagent 2, Reagent 3, magnetic separation reagent, calibrator and quality control. (Please refer to the product manual for details)
试剂盒由试剂2、试剂3、磁分离试剂、校准品和质控品组成。（具体内容详见产品说明书）
Store at 2~8°C, valid for 12 months.
2～8℃保存，有效期12个月。
- Changes
- 2020-03-31 增加适用机型及文字性变更。具体内容详见附件。请申请人参照变更批件及附件自行修订说明书和中文标签中的相关内容。 2021-08-12 “生产地址:北京市北京经济技术开发区兴海路5号2层、6层、B1层”变更为“生产地址:北京市北京经济技术开发区兴海路5号1幢 2层、6层、B1层、2幢”。 2022-05-23 1.产品技术要求内容变更。2.请注册人依据变更文件自行修订产品技术要求中相应内容。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Hepatitis B virus e antibody (HBeAb) assay kit (Chemiluminescent magnetic particle 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20173401374 and owned by Beijing Leadman Biochemistry Co., Ltd.. The device was approved on July 18, 2022.
This page provides complete registration details including registrant information, province location (Beijing), 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.