U.S. FDA issued EUA for new COVID-19 over-the-counter at-home antigen test

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On Apr. 14, 2023, the U.S. FDA issued an emergency use authorization for the Azure Fastep COVID-19 Antigen Pen Home Test (manufactured by Azure Biotech), an OTC COVID-19 antigen diagnostic test that showed results in 15 minutes.

The test can be used for serial testing for people who have symptoms within the first 6 days of symptoms or for people who do not have symptoms and undergo additional testing.

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Source: U.S. Food and Drug Administration
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