Human Immunodeficiency Virus Antigen/Antibody Assay Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 国械注准20243400577
Access comprehensive regulatory information for Human Immunodeficiency Virus Antigen/Antibody Assay Kit (Magnetic Particle Chemiluminescence 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20243400577 and owned by Beijing BGI-GBI Biotech Co., Ltd.. The device was approved on March 21, 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.
This product is used for the in vitro qualitative detection of HIV-1/HIV-2 antibody and HIV-1 p24 antigen in human serum or plasma samples.
本产品用于体外定性检测人体血清或血浆样本中的HIV-1/HIV-2抗体和HIV-1 p24抗原。
Reagent Pack, HIV Control 1, HIV Control 2, Information Card. (Please refer to the product manual for details)
试剂包、HIV 对照品1、HIV 对照品2、信息卡。(具体内容详见产品说明书)
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期12个月。