Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Wincot). ARTG record, intended purpose,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
The EasyMate Multi-Function Monitoring System is a clinical chemistry reagent/substrate, used in conjunction with the EasyMate analysers, calibrators and controls for the measurement of blood glucose. uric acid, cholesterol and haemoglobin in human capillary blood. This system is used for home-use and point-of-care environments.