Hepatitis B virus core antibody IgM detection test kit (magnetic particle chemiluminescence) - NMPA Registration 国械注准20243400447
Access comprehensive regulatory information for Hepatitis B virus core antibody IgM detection test kit (magnetic particle chemiluminescence) 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20243400447 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 B virus core antibody IgM (anti-HBc-IgM) in human serum or plasma samples.
用于体外定性检测人体血清或血浆样本中的乙型肝炎病毒核心抗体IgM（抗-HBc-IgM）。
This kit contains a reagent pack, anti-HBc-IgM reference 1, anti-HBc-IgM control 2, and an information card. (Please refer to the manual for details)
本试剂盒含有试剂包、抗-HBc-IgM对照品1、抗-HBc-IgM对照品2、信息卡。（具体内容详见说明书）
Store at 2~8°C, valid for 12 months.
2~8℃保存，有效期12个月。