幽门螺杆菌IgG抗体对照品 - NMPA Registration 国械注准20253400209
Access comprehensive regulatory information for 幽门螺杆菌IgG抗体对照品 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20253400209 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.
本产品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）、幽门螺杆菌IgG抗体质控品配合使用，用于确定幽门螺杆菌IgG抗体检测项目的阳性判断值。
对照品C0：幽门螺杆菌IgG抗体为阴性的牛血清白蛋白的MES缓冲基质的液体，含防腐剂；对照品C1：幽门螺杆菌IgG抗体为阳性的牛血清白蛋白的MES缓冲基质的液体，含防腐剂；信息卡。（具体内容详见说明书）
Store at 2~8°C, valid for 18 months.
2～8℃保存，有效期为18个月。