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The U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) at-home COVID-19 antigen test.
The Genabio COVID-19 Rapid Self-Test is an OTC COVID-19 antigen diagnostic test that shows results in 15 minutes.
The test can be used as:
- A single test for people with COVID-19 symptoms
- A serial test for people with or without symptoms, meaning the test is done two times over three days, with at least 24 hours and no more than 48 hours between tests.
The test can be used for people:
- Age 14 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
The Emergency Use Authorization (EUA) issued to Genabio Diagnostics Inc. for their Genabio COVID-19 Rapid Self-Test is the latest example of the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests, and to facilitate access to these tests for all Americans.
Questions?
If you have questions about this EUA announcement, contact the Division of Industry and Consumer Education.
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