Device Dossier

Viral infectious disease IVDs

Device Dossier for Viral infectious disease IVDs (CT355 - Viral infectious disease IVDs, Class 2, sponsor ESL Biosciences Australia 2012). ARTG record,…

Intended purpose

IVDs that are intended to be used to determine(qualitative and or quantitative) information about infection with or exposure to one or a number of viral diseases in a clinical specimen. Each IVD is intended to be used by a medical laboratory scientist. Techniques used include: ELISA, Indirect Immunofluorescence, immune blots or western blot

TGA Public Summary