SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

This category includes in vitro diagnostic test kits designed to detect immunoglobulin G (IgG) antibodies specific to SARS-CoV-2 in human clinical specimens. These kits use a chemiluminescent immunoassay method to qualitatively or quantitatively measure IgG antibodies, aiding in the assessment of prior exposure to or immune response against the virus that causes COVID-19.

Devices in this category are regulated as in vitro diagnostic medical devices and are supplied as complete reagent systems requiring compatible instrumentation for use. They are intended for professional use in laboratory settings and are not intended for self-testing or point-of-care use without appropriate validation and oversight.