Device Dossier

Clinical chemistry-specific protein IVDs

Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor Lumos Diagnostics). ARTG…

Intended purpose

FebriDX is a rapid immunoassay for the visual, qualitative, in vitro detection of elevated levels of both MxA and CRP directly from finger-stick whole blood. The test measures a clinically significant immune response to a suspected invasive viral and/or bacterial infection in patients. This is intended for professional use by a trained health service provider.

TGA Public Summary