Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

24 devices · GMDN 49689

This category includes rapid test kits designed to detect heterophile antibodies in clinical specimens, which are produced by the body in response to Epstein-Barr virus (EBV) infection. These tests use an immunochromatographic method (lateral flow) to provide quick qualitative or semi-quantitative results, aiding in the diagnosis of infectious mononucleosis in laboratory or point-of-care settings.

Devices in this category are intended for professional use only and are not suitable for self-testing. They are regulated as in vitro diagnostic medical devices and are supplied as complete kits containing all necessary reagents and materials for performing the test, with results available in a short time compared to standard laboratory procedures.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category