Covid Test Makers Must Alter Labels for Repeat Testing, FDA Says

Nov. 2, 2022, 6:26 PM UTC

Abbott Laboratories Inc. and other companies that received FDA authorizations for Covid-19 antigen tests must now update their labels to allow for use at least twice over a three-day period.

The Food and Drug Administration announced Tuesday that it had notified all developers of Covid-19 in vitro diagnostics that received emergency use authorizations of changes to their authorized uses for serial, or repeat, testing. Diagnostics previously authorized for testing of symptomatic individuals can now be used at least twice over three days, with at least 48 hours between tests, the FDA said.

The agency is also allowing tests authorized for ...

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