Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Ical & Trading Co). ARTG record,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
The Lipid Panel Monitoring System is composed of the Lipid Panel Meter and Lipid Panel Test Cartridges. The Lipid Panel Monitoring System is intended for quantitatively measuring the concentration of Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL) and Triglyceride (TG) with capillary whole blood sample or venous whole blood. The system is intended for professional use. It is used for in-vitro diagnostic use only.