Device Dossier

Clinical chemistry-specific protein IVDs

Device Dossier for Clinical chemistry-specific protein IVDs (CT974 - Clinical chemistry-specific protein IVDs, Class 2, sponsor MAG Pharma). ARTG record,…

Intended purpose

The Food Xplorer (FOX) is an Enzyme-Linked Immunosorbent Assay (ELISA) – based in-vitro diagnostic tests for the semi-quantitative measurement of specific immunoglobulin G (IgG) against 286 food antigens. The Food Xplorer is suitable for use with serum or plasma. FOX can be used to support dietary clarification and to monitor dietary compliance. Furthermore, FOX can be used in case of reasonable suspicion of immunologically caused food intolerance. Before starting a diet based on FOX results, it is important to discuss the results with a physician or a dietician. The processing of FOX should always be carried out by professionally trained personnel and/or medical professionals.

TGA Public Summary