China NMPA legacy archive 豫械注准20252400024Osteocalcin calibration kit
骨钙素校准品
Autobio Diagnostics Co., Ltd.Class IINMPAApproved January 10, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- 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.
- Approval department
- Henan Provincial Drug Administration
0.6mL×2瓶/盒，0.6mL×4瓶/盒，1.0mL×2瓶/盒，1.0mL×4瓶/盒。
河南省药品监督管理局
Registration information
- Registration number
- 豫械注准20252400024
- Approval date
- January 10, 2025
- Expiry date
- January 09, 2030
Registrant
- Province/Region
- Henan
- Address
- No. 87, Jingbei 1st Road, Zhengzhou Economic and Technological Development Zone
河南
郑州经济技术开发区经北一路87号
Production facility
- Production address
- 郑州经济技术开发区经开第十五大街199号
Intended use
English
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。
Structure and composition
English
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。
Storage conditions and expiration
English
Store at 2°C~8°C, valid for 18 months.
中文
2℃～8℃储存,有效期18个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for Osteocalcin calibration kit, registration 豫械注准20252400024. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.