Quidel’s received amended Emergency Authorization for rapid antigen COVID-19 diagnostic assay
On Jun. 9, 2020, Quidel announced it had received an amended Emergency Use Authorization (EUA) from the FDA, allowing Quidel to run its Sofia SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofiaᆴ Fluorescent Immunoassay Analyzer (‘Sofia 1’), Quidel’s first-generation automated immunoassay instrument. Quidel previously received EUA to run the Sofia SARS Antigen FIA on the second-generation Sofia 2 instrumented system.
Tags:
Source: Reuters
Credit: