Is the covidSHIELD test authorized by the FDA?

Is the covidSHIELD test authorized by the FDA?

Yes! The covidSHIELD test has had FDA Emergency Use Authorization ("EUA") since March 1st, 2021. The EUA was updated to increase the scope of the test on April 2nd, 2021. Information about the covidSHIELD EUA from the FDA can be found here:

  1. Most Recent Letter of Authorization: https://www.fda.gov/media/146314/download
  2. EUA Summary: https://www.fda.gov/media/146317/download
  3. Patient Fact Sheet: https://www.fda.gov/media/146316/download
  4. Healthcare Provider Fact Sheet: https://www.fda.gov/media/146315/download

You may have seen something like "Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing" in the news or on social media. This pertains only to one specific test which was developed BY the CDC. The EUA for covidSHIELD remains valid.  For a full list of In Vitro Diagnostics EUAs - Molecular Dianostic Tests for SARS-Cov-2 visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#amendment


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