FDA grants Hardy Diagnostics EUA for COVID-19 antibody test

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May 5, 2020—Hardy Diagnostics announced FDA EUA approval of the Anti-SARS-CoV-2 Rapid Test.

The Anti-SARS-CoV-2 Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (heparin/ EDTA/sodium citrate) or serum from individuals who are suspected of having COVID-19 infection. Turnaround time is 15 minutes.