FDA Authorizes Another COVID-19 Over-the-Counter Test
The U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) COVID-19 test. The FDA is committed to increasing the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests and to facilitating consumer access to these tests.
The FDA issued an emergency use authorization (EUA) for the iHealth COVID-19 Antigen Rapid Test, an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes.
The test can be used as:
- A single test for people with COVID-19 symptoms.
- A serial test for people without symptoms, meaning the test is done two times over three days.
The test can be used for people:
- Age 15 years or older with a self-collected nasal swab sample.
- Age 2 years or older when an adult collects the nasal swab sample.
Questions?
If you have questions about OTC COVID-19 tests, contact the Division of Industry and Consumer Education.
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