甲状腺素校准品 - NMPA Registration 豫械注准20252400052
Access comprehensive regulatory information for 甲状腺素校准品 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20252400052 and owned by Autobio Diagnostics Co., Ltd.. The device was approved on January 14, 2025.
This page provides complete registration details including registrant information, province location (Henan), 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.
本产品用于本公司适配检测系统上，对郑州安图生物工程股份有限公司的甲状腺素检测试剂盒（磁微粒化学发光法）进行校准。
本产品由校准品（含化学合成的甲状腺素抗原，基质液为含防腐剂Proclin300的人血清，浓度约为2.0 μg/dL、15.0 μg/dL，具体浓度以标定结果为准）和条码卡（含校准品赋值信息）组成。
2℃～8℃储存；有效期：18个月。