Device Category Dossier

CT944 - Software IVDs

Device Category Dossier for CT944 - Software IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Software

IVDs are software intended to influence in vitro diagnostic instruments and analysers , operating across diverse laboratory platforms including liquid handling instruments for sample processing , urinalysis systems and reagent delivery components , and digital slide microscopes for image review and interpretation . These software applications support human genetic pathology testing , urinalysis testing , and pathologist case management and qualitative image review across clinical laboratory diagnostic workflows.