Device Dossier
Bordetella IVDs
Device Dossier for Bordetella IVDs (CT778 - Bordetella IVDs, Class 3, sponsor Hologic (Australia & New Zealand)). ARTG record, intended purpose, GMDN…
- GMDN category: CT778 - Bordetella IVDs
Intended purpose
The Panther Fusion Bordetella assay is a multiplex real-time PCR in vitro diagnostic test for the rapid and qualitative detection and differentiation of Bordetella pertussis (Bp) and Bordetella parapertussis (Bpp). This assay is intended to aid in the differential diagnosis of Bordetella pertussis and Bordetella parapertussis infections in humans.