17 devices · GMDN 49662
This category includes in vitro diagnostic (IVD) kits designed to detect immunoglobulin M (IgM) antibodies specific to Epstein-Barr virus (EBV) in patient samples such as blood or serum. These kits use an enzyme immunoassay (EIA) method to support the clinical assessment of recent or acute EBV infection, which is associated with conditions like infectious mononucleosis and glandular fever.
Devices in this category are supplied as complete reagent kits containing all necessary components for performing the assay and are regulated as IVD medical devices. They are intended for use by trained laboratory professionals in clinical settings and are not intended for self-testing or point-of-care use unless specifically labeled otherwise by the manufacturer.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.