Device Category Dossier

CT701 - Infectious disease IVDs

Device Category Dossier for CT701 - Infectious disease IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Infectious disease in vitro diagnostic devices are intended to be used in testing to provide information about infection with or exposure to infectious agents capable of causing disease, including viruses, bacteria, fungi, parasites and/or prions. These devices are used clinically to aid in diagnosis of conditions such as syphilis, meningitis and encephalitis from cerebrospinal fluid specimens, and COVID-19 in symptomatic or asymptomatic individuals across various healthcare settings.