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Here are the 12 coronavirus (COVID-19) antibody tests that have FDA authorization

Manufacturers now required to apply for Emergency Use Authorization

Coronavirus testing
Coronavirus testing (AP)

DETROIT – The U.S. Food and Drug Administration is tightening the rules on coronavirus (COVID-19) antibody testing.

Officials have issued a new policy requiring manufacturers to apply for Emergency Use Authorization within 10 days of when a test is validated.

The former policy, which was issued in March, allowed companies to validate their own tests and sell them, as long as they had a disclaimer that they hadn’t been approved by the FDA.

But FDA officials have since learned of companies making false claims about tests and their accuracy.

So far, 12 antibody tests have been issued Emergency Use Authorization from the FDA. You can see the full list, along with the dates of authorization, below.


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