China NMPA legacy archive 湘械注准20252400077Blood lipid control solution
血脂质控液
Sinocare Inc.Class IINMPAApproved January 15, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 水平1（4mL ×1）、水平2（4mL ×1）
- Approval department
- Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration information
- Registration number
- 湘械注准20252400077
- Approval date
- January 15, 2025
- Expiry date
- January 14, 2030
Registrant
- Province/Region
- Hunan
- Address
- No. 265, Guyuan Road, Changsha High-tech Industrial Development Zone
湖南
长沙高新技术产业开发区谷苑路265号
Production facility
- Production address
- 长沙高新技术产业开发区谷苑路265号
Intended use
English
用于血脂指标（总胆固醇和甘油三酯）测试系统检测过程中的质量控制。
Structure and composition
English
由稳定剂(0.001％-2％)、抗菌剂(0.1％-2％)、缓冲液(90％-95％)、甘油(0.01％-2％)和胆固醇(0.01％-2％)组成。
Storage conditions and expiration
English
储存条件：储存温度5℃～30℃，储存湿度≤95％RH。 请在规定的储存条件下储存；请勿让阳光长时间直接照射质控液；质控液存放不当，可能对检验结果产生影响。有效期：未开瓶产品的有效期为6个月，开瓶后产品有效期为3个月，两者以先到的日期为准。使用后应立即将瓶盖拧严，并将开瓶日期标注于质控液标签上。
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 Blood lipid control solution, registration 湘械注准20252400077. 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.