Device Category Dossier

CT354 - Fungal infectious disease IVDs

Device Category Dossier for CT354 - Fungal infectious disease IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Fungal infectious disease in vitro diagnostic devices detect nucleic acid sequences or antigens specific to fungal pathogens in human specimens to provide information about infection with or exposure to yeast and fungal diseases. These devices are used as aids in diagnosis for respiratory infections caused by fungal pathogens and dermatophyte infections of the nails.