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Home » Quidel wins first non-EUA COVID test authorization for Sofia rapid antigen test
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Quidel wins first non-EUA COVID test authorization for Sofia rapid antigen test

March 9, 2023
By Mark McCarty
The FDA’s emergency use authorization (EUA) program for rapid antigen tests for the COVID-19 pandemic is coming to an end, but few rapid antigen test makers have laid out clear plans regarding the post-public health emergency world. Quidelortho Corp. managed to beat the competition to the non-EUA market for these tests with a grant of de novo petition for its Sofia rapid antigen test, which now provides other tests with a predicate device, thus ensuring that this will not be the last such test to reach the U.S. market.
BioWorld MedTech Coronavirus U.S.

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