Device Dossier

Bordetella IVDs

Device Dossier for Bordetella IVDs (CT778 - Bordetella IVDs, Class 3, sponsor DiaSorin). ARTG record, intended purpose, GMDN category — compiled by…

Intended purpose

For the in vitro qualitative detection and discrimination of Bordetella pertussis and Bordetella parapertussis in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of bacterial respiratory tract infection. For use on the 3M Integrated Cycler instrument.

TGA Public Summary