Hepatitis B virus surface antigen determination reagent kit (chemiluminescence immunoassay method) - NMPA Registration 国械注准20243400760
Access comprehensive regulatory information for Hepatitis B virus surface antigen determination reagent kit (chemiluminescence immunoassay 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20243400760 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on April 24, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
本产品用于体外定量检测人血清和（或）血浆中乙型肝炎病毒表面抗原的含量。
It is mainly composed of magnetic particles (R1), enzyme markers (R2), calibrator 1, calibrator 2, quality control 1, and quality control 2. (Please refer to the product manual for details)
主要由磁微粒（R1）、酶标记物（R2）、校准品1、校准品2、质控品1、质控品2组成。（具体内容详见产品说明书）
It can be stored in the dark at 2~8°C, and can be stored stably for 12 months.
2～8℃环境下避光储存，可稳定保存12个月。