FDA Authorizes Another OTC COVID-19 Test

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FDA - Center for Devices and Radiological Health

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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.