异常凝血酶原检测试剂盒(化学发光免疫分析法) - NMPA Registration 国械注准20243402400
Access comprehensive regulatory information for 异常凝血酶原检测试剂盒(化学发光免疫分析法) 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20243402400 and owned by Getein Biotech, Inc.. The device was approved on November 27, 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.
本试剂盒用于体外定量检测人血清、血浆中异常凝血酶原(PIVKA Ⅱ)的浓度.主要用于对已确诊肝癌患者进行动态监测以辅助判断疾病进展或治疗效果,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.
本试剂盒用于体外定量检测人血清、血浆中异常凝血酶原（PIVKA Ⅱ）的浓度。主要用于对已确诊肝癌患者进行动态监测以辅助判断疾病进展或治疗效果，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。
链亲和素包被的磁性微粒,校准品L,校准品H,吖啶酯标记的异常凝血酶原单克隆小鼠抗体,生物素标记的异常凝血酶原单克隆小鼠抗体.(具体内容详见产品说明书)
链亲和素包被的磁性微粒，校准品L，校准品H，吖啶酯标记的异常凝血酶原单克隆小鼠抗体，生物素标记的异常凝血酶原单克隆小鼠抗体。（具体内容详见产品说明书）
未开瓶试剂2~8℃保存,有效期为12个月.
未开瓶试剂2~8℃保存，有效期为12个月。