CE marked and FDA 510(K) Number K192123. The SARS-CoV-2 IgM/IgG Ab Rapid Test is used to detect the IgM and IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma, or whole blood sample qualitatively. It is to be used as an aid in the diagnosis of infectious disease. 40T/box, 48 boxes/ctn