Herpes simplex virus type 1 IgG antibody test kit (magnetic particle chemiluminescence method) - NMPA Registration 国械注准20253400211
Access comprehensive regulatory information for Herpes simplex virus type 1 IgG 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20253400211 and owned by Xiamen Innodx BIOTECH Co., Ltd.. The device was approved on January 20, 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.
本试剂用于定性检测人血清和血浆中单纯疱疹病毒1型IgG抗体。
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。（具体内容详见说明书）
Reagents and calibrators are stored at 2~8°C, and quality controls are stored at <-15°C, with an expiration date of 12 months.
试剂和校准品2～8℃保存，质控品＜-15℃保存，有效期12个月。