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

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ACON Laboratories Flowflex COVID-19 Home Test is authorized for home use without a prescription

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FDA - Center for Devices and Radiological Health

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FDA Authorizes Additional COVID-19 Over-the-Counter Home Antigen Test

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter COVID-19 antigen test.

  • It can be used to test both symptomatic and asymptomatic individuals without the need for repeat testing over several days, known as serial testing.
  • The authorization should significantly increase the availability of rapid, at-home tests for consumers and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks. By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022.

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Over-the-Counter and At-Home Tests Remain a High Priority

Since March 2020, the FDA has authorized over 400 COVID-19 tests and sample collection devices, including authorizations for rapid, OTC at-home tests. Today's action highlights the agency's continued commitment to increasing the availability of accurate and reliable at-home COVID-19 diagnostic tests, and to facilitating consumer access to these tests. 

Questions?

If you have questions about this EUA announcement, contact the Division of Industry and Consumer Education


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