Monday, November 22, 2021

FDA Authorizes InBios SCoV-2 Ag Detect Rapid Self-Test

InBios SCoV-2 Ag Detect Rapid Self-Test delivers results in about 20 minutes; available without a prescription

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FDA - Center for Devices and Radiological Health

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

The U.S. Food and Drug Administration (FDA) authorized another over-the-counter (OTC) COVID-19 antigen 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 InBios SCoV-2 Ag Detect Rapid Self-Test, an OTC COVID-19 antigen diagnostic test that delivers results in about 20 minutes.

The test can be used as:

  • A single test for people with COVID-19 symptoms within the first five days of symptom onset.
  • 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 14 years or older with a self-collected nasal swab sample.
  • Age 2 years or older when an adult collects the nasal swab sample.

Read More

Questions?

If you have questions about OTC COVID-19 tests, see Coronavirus Disease 2019 Testing Basics.


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