Thyroglobulin Antibody Calibration Kit - NMPA Registration 豫械注准20252400053
Access comprehensive regulatory information for Thyroglobulin Antibody Calibration Kit 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20252400053 and owned by Autobio Diagnostics Co., Ltd.. The device was approved on January 15, 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生产的甲状腺球蛋白抗体检测试剂盒（磁微粒化学发光法）（TgAb）进行校准。
本产品由校准品（含人源甲状腺球蛋白抗体，浓度约为10IU/mL 、1000IU/mL，基质液为含Proclin300的Tris缓冲液，具体浓度以标定结果为准）和条码卡（含产品基本信息和校准品赋值信 息）组成。
2℃～8℃储存; 有效期18个月。