Device Dossier
Parasitic infectious diseases IVDs
Device Dossier for Parasitic infectious diseases IVDs (CT356 - Parasitic infectious diseases IVDs, Class 2, sponsor ESL Biosciences Australia 2012). ARTG…
- GMDN category: CT356 - Parasitic infectious diseases IVDs
Intended purpose
Parasitic etc IVDs that are intended to be used to determine (qualitative and or quantitative) information about the presence of, or infection with one or a number of parasitic organisms including protozoa, amoebae, nematodes and/or other worms 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