Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic kits designed to detect immunoglobulin G (IgG) antibodies specific to cytomegalovirus (CMV) in patient samples such as serum or plasma. These kits use an enzyme immunoassay (EIA) format to support clinical assessment of past or current CMV infection, particularly in immunocompromised individuals, pregnant women, or transplant recipients.

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 personnel and are regulated as in vitro diagnostic medical devices based on their intended use for detecting CMV IgG antibodies via EIA methodology.