FDA authorizes INDICAID COVID-19 Rapid Antigen At-Home Test

U.S. Food and Drug Administration sent this bulletin at 03/18/2022 10:06 AM EDT

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FDA - Center for Devices and Radiological Health

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FDA Authorizes INDICAID COVID-19 Over-the-Counter At-Home Antigen Test

The U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) at-home COVID-19 antigen test. The emergency use authorization (EUA) issued to PHASE Scientific International, Ltd. for their INDICAID COVID-19 Rapid Antigen At-Home Test is another example of the FDA’s 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.

The INDICAID COVID-19 Rapid Antigen At-Home Test is an OTC at-home COVID-19 antigen diagnostic test that delivers results in 20 minutes.

The test can be used as:

  • A single test for people in the first 6 days of COVID-19 symptoms onset.
  • 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.

It 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.

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