Device Dossier
Bordetella IVDs
Device Dossier for Bordetella IVDs (CT778 - Bordetella IVDs, Class 3, sponsor Roche Diagnostics). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: CT778 - Bordetella IVDs
Intended purpose
IVDs that are intended to be used in testing to provide information about infection with or exposure to Bordetella bacteria using nasopharyngeal swabs. The test is intended for professional use in a clinical laboratory, near-patient, or point-of-care setting