总胆固醇试条（干化学法） - NMPA Registration 湘械注准20252400010
Access comprehensive regulatory information for 总胆固醇试条（干化学法） in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20252400010 and owned by Sinocare Inc.. The device was approved on January 03, 2025.
This page provides complete registration details including registrant information, province location (Hunan), 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.
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。
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。
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。