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…

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.

TGA Public Summary