Device Dossier

Fungal infectious disease IVDs

Device Dossier for Fungal infectious disease IVDs (CT354 - Fungal infectious disease IVDs, Class 2, sponsor Briggate Medical Company). ARTG record,…

Intended purpose

The Dermatophyte Test Strip "Diafactory Tinea Unguium" is intended for the qualitative detection of dermatophyte antigens from toenails and fingernails. This kit is intended to be used as an aid in the diagnosis of Dermatophyte infection in fingernails and toenails.

TGA Public Summary