三碘甲状腺原氨酸校准品
- Device class
- Class II
- Model specifications
- 0.6mL×2瓶/盒,0.6mL×4瓶/盒,1.0mL×2瓶/盒,1.0mL×4瓶/盒.0.6mL×2瓶/盒，0.6mL×4瓶/盒，1.0mL×2瓶/盒，1.0mL×4瓶/盒。
- Approval department
- Henan Provincial Drug Administration河南省药品监督管理局
- Registration number
- 豫械注准20252400051
- Approval date
- January 14, 2025
- Expiry date
- January 13, 2030
- Name
- Autobio Diagnostics Co., Ltd.郑州安图生物工程股份有限公司
- Province/Region
- Henan河南
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone郑州经济技术开发区经北一路87号
- Production address
- 郑州经济技术开发区经开第十五大街 199号
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三碘甲状腺原氨酸检测试剂盒（磁微粒化学发光法）进行校准。
本产品由校准品（含三碘甲状腺原氨酸（化学品），基质液为含防腐剂Proclin300的人血清，浓度约为0.3ng/mL、5.0ng/mL，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。
Store at 2°C~8°C, valid for 18 months.
2℃～8℃储存，有效期18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for 三碘甲状腺原氨酸校准品 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20252400051 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.