Device Category Dossier

CT778 - Bordetella IVDs

Device Category Dossier for CT778 - Bordetella IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

In vitro diagnostic devices detect

Bordetella bacteria using nucleic acid amplification or antibody detection methods from respiratory samples to identify infection or exposure. These tests are used in clinical laboratory and point-of-care settings to aid in the diagnosis of respiratory infections caused by Bordetella pertussis and Bordetella parapertussis in suspected patients.