Anti-Mullerian hormone (AMH) detection reagent kit (fluorescent immunochromatography) - NMPA Registration 京械注准20232400295
Access comprehensive regulatory information for Anti-Mullerian hormone (AMH) detection reagent kit (fluorescent immunochromatography) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20232400295 and owned by Beijing Tigsun Diagnostics Co., Ltd.. The device was approved on May 06, 2023.
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 kit is used for the quantitative determination of anti-Mullerian hormone (AMH) content in human serum and plasma in vitro.
本试剂盒用于体外定量测定人血清、血浆中抗缪勒管激素(AMH)的含量。
Note: 1. This product is traced to the enterprise work calibration product; 2. The components in different batch kits cannot be interchanged, and the calibration information cards and reagents of different batch numbers cannot be mixed.
注：1、本产品溯源至企业工作校准品； 2、不同批号试剂盒中各组分不能互换，不同批号的校准信息卡和试剂不能混用。
The kit was stored at 2°C~30°C
试剂盒2℃～30℃条件下储存