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FDA Grants Hardy Diagnostics EUA for COVID-19 Rapid Antibody Test Kit americanpharmaceuticalreview
May 13, 2020
Hardy Diagnostics has received approval for a new in vitro diagnostic medical device: Anti-SARS-CoV-2 Rapid Test under the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA).
FDA Grants EUA for Cardiac Monitoring in COVID-19 Patients americanpharmaceuticalreview
May 11, 2020
VitalConnect® announced it was granted Emergency Use Authorization (EUA) status by the U.S. Food and Drug Administration (FDA) as part of the response to the COVID-19 pandemic.
US FDA gives EUA to Roche for COVID-19 antibody test expresspharma
May 05, 2020
The company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a month by the end of the year.
Gilead Granted EUA for Remdesivir in COVID-19 contractpharma
May 04, 2020
Facilitates broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease.
Fluxergy Submits Request for EUA for One-Hour COVID-19 Test at Point-of-Care americanpharmaceuticalreview
April 07, 2020
Fluxergy has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health.
BGI Genomics Receives EUA for SARS-CoV-2 Test Kit contractpharma
March 30, 2020
Test can return results within three hours and is intended for the qualitative detection of the virus that causes COVID-19 disease.
COVID-19 Update: FDA Issues EUA for Point of Care Diagnostic contractpharma
March 24, 2020
First emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.
Abbott's RealTime SARS-CoV-2 Test Receives EUA contractpharma
March 20, 2020
System uses polymerase chain reaction (PCR) technology and has the ability to run high volumes of up to 470 tests in 24 hours.
FDA Issues EUA to Thermo Fisher contractpharma
March 17, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s diagnostic test that can be used immediately...
Roche’s SARS-CoV-2 Test Receives EUA contractpharma
March 16, 2020
First commercial test for SARS-CoV-2 will enable expedited coronavirus testing with results in three and half hours.

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