Device Dossier
Bacterial infectious disease IVDs
Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor VITRYL AUS). ARTG record, intended…
- GMDN category: CT353 - Bacterial infectious disease IVDs
Intended purpose
The H. pylori antibody rapid test is a rapid chromatographic immunoassay for the qualitative detection of HP IgG antibody in serum plasma/whole blood, as an indicator of potential current infection or of previous infection with H. pylori. The test is intended for used by health care professionals.