Alpha-fetoprotein detection kit (fluorescence immunochromatography) - NMPA Registration 国械注准20243400590
Access comprehensive regulatory information for Alpha-fetoprotein detection kit (fluorescence immunochromatography) 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20243400590 and owned by Getein Biotech, Inc.. The device was approved on March 26, 2024.
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.
This kit is used for the quantitative detection of alpha-fetoprotein (AFP) content in human serum and plasma in vitro. It is mainly used for dynamic monitoring of patients with malignant tumors to assist in judging the disease process or treatment effect, and cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and should not be used for tumor screening in the general population.
本试剂盒用于体外定量检测人血清、血浆中甲胎蛋白（AFP）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，不宜用于普通人群的肿瘤筛查。
The kit consists of a test card, a test buffer, an SD card, and a pipette. (Please refer to the product manual for details)
试剂盒由检测卡、检测缓冲液、SD卡、吸管组成。（具体内容详见产品说明书）
The test card is stored at 4~30°C, sealed and valid for 18 months.
检测卡于4～30℃，密封状态下存放，有效期为18个月。