风疹病毒IgM抗体（Rub IgM）检测试剂盒（化学发光免疫分析法） - NMPA Registration 国械注准20253400206
Access comprehensive regulatory information for 风疹病毒IgM抗体（Rub IgM）检测试剂盒（化学发光免疫分析法） 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20253400206 and owned by Guangzhou Kangrun Biotechnology Co., Ltd.. The device was approved on January 20, 2025.
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.
适用于体外定性检测人血清或血浆中的风疹病毒IgM抗体。
由Rub磁珠包被物（R1）、抗人IgM抗体吖啶酯标记物（R2）、反应缓冲液（R3）、Rub IgM阴性对照、Rub IgM阳性对照、复溶液和阴阳性对照信息卡组成。（具体详见说明书）
Store at 2~8 °C in the dark, valid for 18 months.
2～8℃避光保存，有效期18个月。