Covid 19 Igg/igm Serology Test Clia Waived Bx/20

The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma. The test is for professional use only. Indication: Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). 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. About Test Device EUA Authorized CE Mark Gives Positive or Negative Result for COVID-19 virus Read Results in 15 Minutes 24 Month Expiration from Date of Manufacture Contents 25 Test Devices 25 Droppers Buffer Package Insert