FDA Grants EUA For Access Bio’s Lateral Flow COVID-19 Antigen Test
Access Bio joins Abbott as the second company with FDA authorization to distribute PCR, antigen and antibody tests for COVID-19.
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The company expects testing for IgM antibodies will be useful in areas where PCR testing is not keeping up with demand.
First-Ever Point-Of-Care COVID-19 Serology Test Granted EUA By FDA
The US agency on 23 September granted emergency use authorization for the Assure COVID-19 IgG/IgM Rapid Test Device to be used in point-of-care settings like doctor’s offices, hospitals, urgent care centers and emergency rooms. The test requires a fingerstick to draw blood.
Coronavirus Antigen Testing Gets Green Light In Germany
Germany is adjusting the national COVID-19 testing strategy, which from mid-October will include the use of antigen tests.