Hepatitis B virus e antibody (HBeAb) assay kit (Chemiluminescent magnetic particle method) - NMPA Registration 国械注准20173401374
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.
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。