Quidel receives EUA for analyzer

June 25, 2021

Quidel has received an amended emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market Sofia Q, a fluorescent immunoassay analyzer, according to the company, which added that sales of the Sofia Q device will initially be limited to use with the Sofia SARS Antigen FIA in the CLIA and CLIA-waived professional segments.

Sofia Q utilizes Sofia fluorescent technology to provide a test result in 15 minutes. The device can be paired with the downloadable Sofia Q mobile application, which guides the user through the workflow and interprets the test result using a proprietary AI model.

Douglas Bryant, President and Chief Executive Officer of Quidel Corporation, said, “We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace. In the future, we believe Sofia Q will be ideal to serve consumers at home, as well as in schools and workplaces.”

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