COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues EUA for Third At-Home COVID-19 Test to Abbott

FDA maze of regulations

Third at-home test gains FDA authorization, making three at-home COVID-19 tests available in less than a month

The US Food and Drug Administration (FDA) issued an EUA Dec. 16, 2020, for Abbott’s BinaxNOW COVID-19 Ag Card Home Test. This EUA marks the second EUA issued for an at-home COVID-19 test in the same week and the third EUA for this type of test.

“FDA continues to authorize COVID-19 tests that will give more Americans access to greater testing flexibility and options,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. “The BinaxNOW COVID-19 Ag Home Test will have a significant manufacturing footprint with the potential to support testing for millions of people.”

Said Jeffrey Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, “With today’s authorization of the BinaxNOW COVID-19 Ag Card Home Test, there are now three tests that can be used completely at home. We will continue to work with test developers to support the availability of more innovative testing options.”

This third at-home COVID-19 test, the BinaxNOW COVID-19 Ag Card Home Test requires a prescription. The first at-home COVID-19 test available not requiring a prescription only became available the day before Abbott’s at-home test received its EUA. Abbott’s test is an antigen test and does not require instruments to interpret.

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