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.
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.
Germany is adjusting the national COVID-19 testing strategy, which from mid-October will include the use of antigen tests.