Alpha-fetoprotein (AFP) assay kit (magnetic chemiluminescence method) - NMPA Registration 国械注准20243402389
Access comprehensive regulatory information for Alpha-fetoprotein (AFP) assay kit (magnetic 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20243402389 and owned by Weihai Weigao BIOTECHNOLOGY Co., Ltd.. The device was approved on November 27, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.
本产品用于体外定量检测人血清或血浆样本中的甲胎蛋白(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,不能用于普通人群的肿瘤筛查.
本产品用于体外定量检测人血清或血浆样本中的甲胎蛋白（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，不能用于普通人群的肿瘤筛查。
测甲胎蛋白磁微粒、测甲胎蛋白示踪结合物、分析缓冲液、校准品1、校准品2、样本稀释液、质控品.(具体内容详见产品说明书)
测甲胎蛋白磁微粒、测甲胎蛋白示踪结合物、分析缓冲液、校准品1、校准品2、样本稀释液、质控品。（具体内容详见产品说明书）
Store at 2~8°C, valid for 12 months.
2～8℃保存，有效期12个月。