证书范围

• EN ISO 13485
  

  Design and Development, Manufacture, Distribution and Service of In-vitro Diagnostic Analyzers and In-vitro Diagnostic Test Kits used in Detection of Cardiac Markers, Coagulation, Genetic Testing, Disease Status, Infectious Disease, Cancer Markers, Blood Glucose Monitoring including Meters and Strips and Blood Glucose, Ketone Body and Uric Acid Monitoring including Meters and Strips including Home Use

• IVDD Annex IV.3
  

  - Blood Glucose Monitoring Systems
  - Blood Glucose Test Strips
  - SARS-CoV-2 Antigen Rapid Tests for self-testing
  - Blood Glucose, Ketone and Uric Acid System
  - Blood Glucose, Ketone and Uric Acid Meters
  - Ketone Test Strips
  - Uric Acid Test Strips