Device Dossier

Bacterial infectious disease IVDs

Device Dossier for Bacterial infectious disease IVDs (CT353 - Bacterial infectious disease IVDs, Class 2, sponsor ESL Biosciences Australia 2012). ARTG…

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 bacterial 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