China NMPA legacy archive 湘械注准20252400010总胆固醇试条（干化学法）
Sinocare Inc.Class IINMPAApproved January 03, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- M101：2支/盒、5支/盒、10支/盒、25支/盒
- Approval department
- Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration information
- Registration number
- 湘械注准20252400010
- Approval date
- January 03, 2025
- Expiry date
- January 02, 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
总胆固醇试条主要用于定量检测新鲜毛细血管全血中的总胆固醇浓度。本产品可以由专业人士、非专业人士（如高胆固醇血症患者等）在医疗环境、非医疗环境（如家中等）进行总胆固醇浓度监测，临床上主要用于高胆固醇血症的辅助诊断。
Structure and composition
English
总胆固醇试条由PET基板、银电极、碳电极、试剂、保护膜组成。其中试剂的主要组成成分包含胆固醇酯酶（0.02U～2.98U）、胆固醇氧化酶（0.01U～1.02U），过氧化物酶（0.11U～10.05U），还原型电子介体（0.001mg～0.051mg）组成。
Storage conditions and expiration
English
储存条件：温度 5℃～30℃，湿度≤95％RH。有效期：未开封产品的有效期为12个月，瓶装试条开封后的有效期为 3个月，独立包装试条开封后请尽快使用。
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 总胆固醇试条（干化学法）, registration 湘械注准20252400010. 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.