Month: May 2021

ADEXUSDx® COVID-19 Antibody Test Receives FDA Emergency Use Authorization for Point-of-Care Deployment Across U.S.

SPRINGDALE, AR, May 26, 2021 – NOWDiagnostics, Inc. announced today that it has received Emergency Use Authorization (EUA) for its ADEXUSDx® COVID-19 antibody test for use at the point-of-care from the U.S. Food and Drug Administration (FDA). Following the EUA, NOWDiagnostics will begin offering the ADEXUSDx® COVID-19 antibody test for use across a variety of CLIA-waived …

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FDA Grants Emergency Use Authorizations for SARS-CoV-2 Tests From Harvard, NowDiagnostics

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for a molecular SARS-CoV-2 test developed by Harvard University and a point-of-care immunoassay for the virus from NowDiagnostics. Harvard’s Quaeris SARS-CoV-2 Assay is designed to detect the virus’s N and RdRP genes in anterior nasal swab specimens either self-collected or …

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