Alpha-Fetoprotein Test Kit (Chemiluminescence Immunoassay Method) - NMPA Registration 国械注准20243402369
Access comprehensive regulatory information for Alpha-Fetoprotein Test Kit (Chemiluminescence Immunoassay 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20243402369 and owned by URIT MEDICAL Electronic Co., Ltd.. The device was approved on November 21, 2024.
This page provides complete registration details including registrant information, province location (Guangxi), 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中甲胎蛋白(AFP)的浓度.临床上主要用于肝癌患者的治疗监测,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.
本产品用于体外定量检测人血清或血浆中甲胎蛋白（AFP）的浓度。临床上主要用于肝癌患者的治疗监测，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。
磁微粒:甲胎蛋白抗体偶联的磁微粒,酶标试剂:碱性磷酸酶标记的甲胎蛋白抗体,校准品,质控品.(具体内容详见产品说明书)
磁微粒：甲胎蛋白抗体偶联的磁微粒，酶标试剂：碱性磷酸酶标记的甲胎蛋白抗体，校准品，质控品。（具体内容详见产品说明书）
2℃～8℃密封保存,有效期15个月.
2℃～8℃密封保存，有效期15个月。