Heparin-binding protein (HBP) detection reagent kit (fluorescent immunochromatography method) - NMPA Registration 鄂械注准20252405409
Access comprehensive regulatory information for Heparin-binding protein (HBP) detection reagent kit (fluorescent immunochromatography method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鄂械注准20252405409 and owned by Wuhan Easy Diagnosis Biomedicine Co., Ltd.. The device was approved on January 26, 2025.
This page provides complete registration details including registrant information, province location (Hubei), 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.
本检测试剂适用于体外定量检测人血浆中肝素结合蛋白（HBP）的含量。
试剂盒由测试卡、弹夹（AF1型号和AF2型号适配）、干燥剂和定标卡组成。其中，测试卡由测试卡外壳、硝酸纤维素膜（包被有鼠抗人HBP抗体B和羊抗鼠IgG抗体）、荧光结合垫（包被荧光标记的鼠抗人HBP抗体A）、样本垫、吸水纸、PVC板组成；定标卡包含试剂的校准曲线、批次、项目名称、生产日期信息。（具体内容详见说明书）
试剂盒应在2℃～30℃干燥环境下避光保存，有效期为18个月。