胃泌素-17测定试剂盒（化学发光免疫分析法） - NMPA Registration 苏械注准20252400050
Access comprehensive regulatory information for 胃泌素-17测定试剂盒（化学发光免疫分析法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20252400050 and owned by Suzhou Hokapi Biomedical Engineering Co., Ltd.. The device was approved on January 08, 2025.
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.
用于体外定量测定人血清中的胃泌素-17的含量。临床上用于萎缩性胃炎的辅助诊断。
试剂R1：含生物素标记的胃泌素-17单克隆抗体1（约0.5mg/L，鼠源性），0.1M磷酸盐蛋白缓冲液，pH6.0，0.1%ProClin300防腐剂；试剂R2：含吖啶酯标记的胃泌素-17单克隆抗体2（约0.5mg/L，鼠源性），0.1M磷酸盐蛋白缓冲液，pH6.0，0.1% ProClin 300防腐剂；试剂M：含链霉亲和素包被的磁颗粒（约0.9mg/mL），0.01% MIT(甲基异噻唑酮啉)防腐剂；校准品1：含胃泌素-17抗原（约7.5pmol/L，化学合成），pH6.0，MES（2-（N吗啉基）乙磺酸）蛋白缓冲液，0.1% ProClin 300防腐剂；校准品2：含胃泌素-17抗原（约150pmol/L，化学合成），pH6.0，MES（2-（N吗啉基）乙磺酸)蛋白缓冲液，0.1% ProClin 300防腐剂；校准品3：含胃泌素-17抗原（约50pmol/L，化学合成），pH6.0，MES（2-（N吗啉基）乙磺酸）蛋白缓冲液，0.1% ProClin 300防腐剂；溯源：溯源至企业内部校准品；主曲线可通过扫描标签二维码或射频识别（RFID）获得。
2℃～8℃保存，有效期18个月；开封的试剂2℃～8℃保存，可稳定60天。