Device Dossier

Bacterial infectious disease IVDs

Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Abmed Medical Technology). ARTG record,…

Intended purpose

This product is used for in vitro qualitative detection of antibodies to H.pylori in whole blood, serum or plasma to aid in the diagnosis of H.pylori infection. The H.Pylori Antibody Test Kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood,serum or plasma to aid in the diagnosis of H. pylori infection.

TGA Public Summary