Device Category Dossier

CT356 - Parasitic infectious diseases IVDs

Device Category Dossier for CT356 - Parasitic infectious diseases IVDs. Australian ARTG records, sponsors, device class — compiled by arcimedes.

External quality control materials are non assay-specific infectious disease controls intended for use with in vitro diagnostic devices that detect antigens, antibodies and/or nucleic acids for parasitic infectious organisms in plasma, serum or other human samples. Routine use of these controls allows laboratories to evaluate daily performance of their molecular assays and proficiency.