Device Dossier
Mycobacteria IVDs
Device Dossier for Mycobacteria IVDs (CT791 - Mycobacteria IVDs, Class 3, sponsor DiaSorin). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: CT791 - Mycobacteria IVDs
Intended purpose
The device uses chemiluminescent immunoassay (CLIA) technology for the detection of interferon-γ (IFN-γ) in human lithium heparin plasma specimens. The immunoassay can identify in vitro responses to a peptide antigens cocktail associated with Mycobacterium tuberculosis (M. tuberculosis) infection (including disease). The assay is an indirect test intended as an aid in the diagnosis of M. tuberculosis infection.