Device Dossier

Fungal infectious disease IVDs

Device Dossier for Fungal infectious disease IVDs (CT354 - Fungal infectious disease IVDs, Class 2, sponsor R-Biopharm). ARTG record, intended purpose,…

Intended purpose

For in vitro diagnostic use. RIDA®GENE Pneumocystis jirovecii is a multiplex realtime PCR for the direct qualitative and quantitative detection of Pneumocystis jirovecii from human bronchoalveolar lavage fluid (BAL). The RIDA®GENE Pneumocystis jirovecii multiplex real-time PCR is intended to use as an aid in diagnosis for respiratory infections caused by Pneumocystis jirovecii.

TGA Public Summary