Hepatitis E virus IgG antibody detection reagent kit (magnetic particle chemiluminescence assay) - NMPA Registration 国械注准20243400445
Access comprehensive regulatory information for Hepatitis E virus IgG antibody detection reagent kit (magnetic particle chemiluminescence 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20243400445 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on March 05, 2024.
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.
It is used for in vitro qualitative detection of hepatitis E virus IgG antibody in human serum or plasma samples.
用于体外定性检测人体血清或血浆样本中戊型肝炎病毒IgG抗体。
Reagent Pack, HEV IgG Control 1, HEV IgG Control 2, Info Card. (Please refer to the product manual for details)
试剂包、HEV IgG对照品1、HEV IgG对照品2、信息卡。（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。