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BioWorld - Thursday, March 23, 2023
See today's BioWorld MedTech
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
No Comments
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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