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Accelerate Diagnostics Announces FDA Emergency Use Authorization For COVID-19 Individual IgM and IgG Antibody Tests


Benzinga | Sep 10, 2020 09:03AM EDT

Accelerate Diagnostics Announces FDA Emergency Use Authorization For COVID-19 Individual IgM and IgG Antibody Tests

TUCSON, Ariz., Sept. 10, 2020 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ:AXDX) and BioCheck, Inc., a privately-held San Francisco-based company focused onin vitrodiagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the individual BioCheck SARS-CoV-2 IgM Test Kit and the BioCheck SARS-CoV-2 IgG Test Kit. Today's announcement follows the recent EUA approval of the fully automated MS-Fast instrument and the BioCheck SARS-CoV-2 IgM and IgG Combo Test.






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