Device Dossier

Parasitic infectious diseases IVDs

Device Dossier for Parasitic infectious diseases IVDs (CT356 - Parasitic infectious diseases IVDs, Class 2, sponsor Australian Rickettsial Reference…

Intended purpose

IVDs designed for the detection and semiquantitation of IgG and IgM antibody to Bebesia microti in human serum. Laboratory test only. Cross-reactivity with Plasmodium spp has been documented.

TGA Public Summary