弓形虫IgM抗体（Toxo IgM）检测试剂盒（化学发光免疫分析法） - NMPA Registration 国械注准20253400198
Access comprehensive regulatory information for 弓形虫IgM抗体（Toxo 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20253400198 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.
本试剂盒适用于体外定性检测人血清或血浆中的弓形虫 IgM抗体。
试剂盒由Toxo磁珠包被物（R1）、抗人IgM抗体吖啶酯标记物（R2）、反应缓冲液（R3）、Toxo IgM阴性对照、Toxo IgM阳性对照、复溶液和阴阳性对照信息卡组成。（具体信息详见产品说明书）
未开封试剂，2-8℃避光保存，有效期18个月。