Device Dossier

Bacterial infectious disease IVDs

Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor Thermo Fisher Scientific). ARTG record,…

Intended purpose

IVD consisting of assays and controls for a real time polymerase chain reaction (PCR) intended to be used in testing for the qualitative detection and differentiation of one or a number of bacterial pathogens.

TGA Public Summary