Free prostate specific antigen test kit (chemiluminescence method) - NMPA Registration 国械注准20253400074
Access comprehensive regulatory information for Free prostate specific antigen test kit (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20253400074 and owned by Nanjing Norman Biological Technology Co., Ltd.. The device was approved on January 10, 2025.
This page provides complete registration details including registrant information, province location (Jiangsu), 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.
本试剂盒用于体外定量检测人体血清中的游离前列腺特异抗原（fPSA）的含量。主要用于对恶性肿瘤患者进行动态监测以辅助判断疾病进程或治疗效果，不能作为恶性肿瘤早期诊断或确诊的依据，不能用于普通人群的肿瘤筛查。
本试剂盒由磁珠试剂、吖啶酯标记试剂、质控品、校准品组成。（具体内容详见说明书）
2~8 °C sealed storage, valid for 15 months.
2～8℃密闭保存，有效期15个月。