Alpha-fetoprotein detection test kit (latex immunoturbidimetric method) - NMPA Registration 国械注准20243401408
Access comprehensive regulatory information for Alpha-fetoprotein detection test kit (latex immunoturbidimetric 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20243401408 and owned by Beijing Bioassay Technologies Corporation. The device was approved on August 05, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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 product is used for the quantitative determination of alpha-fetoprotein (AFP) content in human serum and plasma in vitro. Clinically, 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 is not used for tumor screening in the general population.
本产品用于体外定量测定人血清、血浆中甲胎蛋白（AFP）的含量。临床上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，不用于普通人群的肿瘤筛查。
Reagent 1, Reagent 2, calibrator and quality control. (Please refer to the product manual for details)
试剂1、试剂2、校准品和质控品。（具体内容详见产品说明书）
Store at 2°C~8°C in the dark, valid for 18 months.
2℃～8℃避光保存，有效期为18个月。