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COVID-19

Coronavirus (COVID-19) Update

Resource: Coronavirus (COVID-19) Update
Source: U.S. Food and Drug Administration
Synopsis: As of April 16, 2021, 363 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 266 molecular tests and sample collection devices, 75 antibody and other immune response tests, and 22 antigen tests. There are 46 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, four over-the-counter (OTC) at-home antigen tests, and two OTC molecular tests.

Comment: The FDA has authorized 7 antigen tests and 2 molecular tests for serial screening programs. The FDA has also authorized 457 revisions to EUA authorizations.

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