Osteocalcin calibration kit
- 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20252400024
- Approval date
- January 10, 2025
- Expiry date
- January 09, 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
本产品用于本公司全自动化学发光检测仪，对郑州安图生物工程股份有限公司生产的骨钙素检测试剂盒（磁微粒化学发光法）进行校准。
本产品由校准品（含骨钙素（化学品），基质为含牛血清白蛋白和防腐剂Proclin300的缓冲液，浓度约为5ng/mL、300ng/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 Osteocalcin 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20252400024 and owned by Autobio Diagnostics Co., Ltd.. The device was approved on January 10, 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.