Device Dossier

Bordetella IVDs

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

Intended purpose

Qualitative in vitro diagnostic tests that provide information about infection or exposure to Bordetella bacteria. These devices are intended for use in hospital, reference or state laboratory settings. These devices are not intended for point of care use.

TGA Public Summary