DiaSorin Molecular Receives BARDA Funding to Develop a Rapid COVID-19 Test
The product is expected to be CE marked and submitted to the FDA by the end of March 2020 to consider for emergency use authorization.
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COVID-19: FDA Gives Flexibility to New York State Department of Health, Issues Emergency Use Authorization for Roche Diagnostic
FDA has exercised enforcement discretion to give the New York State Department of Health permission to authorize lab testing for COVID-19.
Read MoreFDA Confers Emergency Use Authorization on Roche’s Cobas SARS-CoV-2 Test
The test is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
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Bio-Rad, through Its Exact Diagnostics Product Line, Launches a SARS-CoV-2 Standard for Coronavirus (COVID-19) Testing
Bio-Rad is providing the SARS CoV-2 Standard to help labs validate their COVID-19 assay results and accelerate access to testing.
Read MoreCerTest Biotec and BD Announce COVID-19 Diagnostic Test
The molecular test for detection of COVID-19 is available to clinical laboratories in countries recognizing the CE mark.
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