肌酐测试条（干化学法） - NMPA Registration 湘械注准20252400011
Access comprehensive regulatory information for 肌酐测试条（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20252400011 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.
本产品主要用于定量检测新鲜毛细血管全血、静脉全血中的肌酐浓度。本产品可以由专业人士和肾病患者、肾透析患者、慢性肾脏病高风险人群等其他有需要人士在医疗机构和/或家庭等非医疗环境进行肌酐浓度监测。肌酐作为肾功能的评价指标之一，临床上主要用于肾脏疾病的辅助诊断。
本产品由试条、密码牌和质控液(选配)组成。试条由银电极、碳电极、试剂、保护膜、亲水膜、双面胶和PET基板组成,其中试剂的主要组成成分包含肌酐酶(＞3U)、肌酸酶(＞2U)、过氧化物酶(＞0.6U)、肌氨酸氧化酶(＞0.3U)、介质(＞0.3mg)、稳定剂(＞0.01mg)。质控液(选配)由稳定剂(0.001％-2％)、抗菌剂(0.1％-2％)、缓冲液(90％-95％)、着色剂(0.01％～1％)和一定浓度水平(水平1、水平2)的肌酐(0.001％-2％)组成。