Anti-Insulin Antibody Detection Reagent Kit (Chemiluminescence Method) - NMPA Registration 苏械注准20252400057
Access comprehensive regulatory information for Anti-Insulin Antibody Detection Reagent Kit (Chemiluminescence 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 苏械注准20252400057 and owned by Nanjing Norman Biological Technology Co., Ltd.. The device was approved on January 10, 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.
用于体外定性检测人血清和（或）血浆中的抗胰岛素抗体。
A磁珠试剂：磁性微粒（≥0.1%），标记生物素的胰岛素抗原（≥4μg/mL，人源重组），叠氮钠（0.3%），牛血清白蛋白（≥0.1%）。B吖啶酯标记试剂：标记吖啶酯的鼠抗人IgG抗体（≥0.2μg/mL，鼠源），叠氮钠（0.3%），酪蛋白（0.25%，牛源）。C辅助试剂：Tris缓冲液（PH 7.4），叠氮钠（0.3%），酪蛋白（≥0.25%，牛源）。抗胰岛素抗体质控品（选配）：冻干粉，含两种浓度抗胰岛素抗体（IAA，人源重组）的磷酸盐缓冲液基质（20mmol/L，pH7.4）。质控品水平1的COI范围为0.35~0.65；水平2的COI范围为1.4~2.6。抗胰岛素抗体校准品（选配）：冻干粉、含两种浓度抗胰岛素抗体（IAA，人源重组）的磷酸盐缓冲液基质（20mmol/L，pH7.4）。校准品水平1的COI范围为0.35~0.65；水平2的COI范围为1.4~2.6。另外，还配备含有定标曲线的射频卡。
试剂2-8℃保存稳定15个月，避免冷冻。开瓶后2-8℃保存可稳定31天。质控品和校准品2-8℃密封保存有效期15个月。复溶后2-8℃保存可稳定7天。