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FDA Authorizes Additional Indication for BinaxNOW COVID-19 Over-the-Counter Antigen Test
The U.S. Food and Drug Administration (FDA) reissued the emergency use authorization (EUA) for the Abbott Diagnostics Scarborough, Inc. BinaxNOW COVID-19 Antigen Self Test.
The BinaxNOW COVID-19 Antigen Self Test gives results in 15 minutes and can be used:
- Without a prescription.
- As a single test for people with COVID-19 symptoms.
- As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.
- For people age 15 years and older with a self-collected nasal swab sample or people age 2 years and older when an adult collects the nasal swab sample.
The FDA reissued the EUA to authorize use of BinaxNOW COVID-19 Antigen Self Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms and as a single use test with a prescription for symptomatic people who are suspected of COVID-19 by their health care provider.
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.
Questions?
If you have questions about OTC COVID-19 tests, contact the Division of Industry and Consumer Education.
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