China NMPA legacy archive 湘械注准20252400011肌酐测试条（干化学法）
Sinocare Inc.Class IINMPAApproved January 03, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class II
- Model specifications
- 试条:Cr1 Air、AffirmNow，10支/盒、20支/盒、25支/盒、50支/盒、 100支/盒、150支/盒。质控液(选配):包装规格1:水平1 (4mL×1);包装规格 2:水平2 (4mL×1);包装规格 3: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20252400011
- 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
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。
Structure and composition
English
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。
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 肌酐测试条（干化学法）, registration 湘械注准20252400011. 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.