Device Category Dossier

CT355 - Viral infectious disease IVDs

Device Category Dossier for CT355 - Viral infectious disease IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Viral infectious disease in vitro diagnostic devices are molecular or antigen-based tests designed to detect viral pathogens including monkeypox virus DNA and respiratory viruses such as adenovirus and respiratory syncytial virus in human biological samples. These devices are used for laboratory diagnosis of viral infections using clinical specimens such as skin lesion material or nasopharyngeal and oropharyngeal swabs.