Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic test kits designed to detect immunoglobulin M (IgM) antibodies specific to cytomegalovirus (CMV) in patient samples such as blood or serum. These kits use an enzyme immunoassay (EIA) method to support the clinical assessment of recent or active CMV infection, particularly in immunocompromised individuals, pregnant women, or newborns where early detection is critical.

Devices in this category are supplied as complete reagent kits containing all necessary components for performing the assay, including antigens, enzymes, substrates, and controls. They are intended for use in clinical laboratories by trained professionals and are regulated as in vitro diagnostic medical devices, with regulatory requirements varying by jurisdiction based on the intended use and risk profile of the test.