May 4, 2020 / 2:57 PM / 25 days ago

U.S. FDA tightens regulations for COVID-19 antibody tests

May 4 (Reuters) - The U.S. Food and Drug Administration said on Monday it expects makers of antibody tests for the new coronavirus to submit requests for emergency use authorization of their tests within 10 days from when the test was validated by a certified lab.

The FDA previously did not expect these submissions if the antibody test was validated and a statement regarding their limitations was included in the test. (bit.ly/2YwBA7d)

Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli

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