幽门螺杆菌IgG抗体质控品 - NMPA Registration 国械注准20253400188
Access comprehensive regulatory information for 幽门螺杆菌IgG抗体质控品 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20253400188 and owned by Shenzhen Mindray Bio-Medical Electronics 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.
与本公司生产的幽门螺杆菌IgG抗体检测试剂盒（化学发光免疫分析法）及幽门螺杆菌IgG抗体对照品配合使用，对检测项目幽门螺杆菌IgG抗体进行质量控制。
幽门螺杆菌IgG抗体质控品（阴性）：约0.6COI，含幽门螺杆菌IgG抗体人血清、牛血清白蛋白的MES缓冲液，防腐剂（ProClin300，NaN3）。幽门螺杆菌IgG抗体质控品（阳性）：约3.0COI，含幽门螺杆菌IgG抗体人血清、牛血清白蛋白的MES缓冲液，防腐剂（ProClin300，NaN3）。
Store at 2~8°C, valid for 18 months.
2~8℃保存，有效期为18个月。