Device: MAGLUMI 2019-nCoV IgM/IgG Company: Shenzhen New Industries Biomedical Engineering Co., Ltd. Indication: Qualitative detection and differentiation of immunoglobulin (IgM) and immunoglobulin G (IgG) to SARS-CoV-2 in human serum and serum in separating gel tubes (SST) using the MAGLUMI 2000 series fully-automated chemiluminescence immunoassay analyzer. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories