Cytomegalovirus IgM Antibody Test Kit (Magnetic Particle Chemiluminescence Method) - NMPA Registration 国械注准20253400077
Access comprehensive regulatory information for Cytomegalovirus IgM Antibody Test 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20253400077 and owned by Xiamen Innodx BIOTECH Co., Ltd.. The device was approved on January 10, 2025.
This page provides complete registration details including registrant information, province location (Fujian), 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.
本试剂盒用于定性检测人血清和血浆中的巨细胞病毒IgM抗体。
Reagent 1, Reagent 2, Reagent 3, Calibrator 1, Calibrator 2, Quality Control 1, Quality Control 2. (Please refer to the product manual for details)
试剂1、试剂2、试剂3、校准品1、校准品2、质控品1、质控品2。（具体内容详见产品说明书）
试剂和校准品2～8℃保存，质控品-20±5℃保存，有效期12个月。