Device Dossier
Bordetella IVDs
Device Dossier for Bordetella IVDs (CT778 - Bordetella IVDs, Class 3, sponsor Becton Dickinson). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: CT778 - Bordetella IVDs
- Sponsor: Becton Dickinson
Intended purpose
Automated real-time qPCR IVDs designed for the qualitative detection of Bordetella spp; in order to provide information about infection with or exposure to Bordetella spp bacteria in patients suspected of respiratory infection, by using nasopharyngeal swabs and nasopharyngeal aspirates.