FDA issues Emergency Use Authorization for Labcorp COVID-19 RT-PCR Test

Rx Only

No descriptive printed matter, advertising and promotional materials, relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

Source:

• 
  April 28, 2021. Denise M. Hinton. “COVID-19 RT-PCR Test EUA200011.” US Food & Drug Administration.
  https://www.fda.gov/media/136148/download.
  Food & Drug Administration.
• 
  May 11, 2021. “COVID-19 RT-PCR Test – EUA Summary.” US Food & Drug Administration.
  https://www.fda.gov/media/136151/download.
  Food & Drug Administration.
• 
  May 24, 2021. Center for Devices and Radiological Health. “In Vitro Diagnostics EUAs.” US Food & Drug Administration.
  https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas.
  Food & Drug Administration.
• 
  July 29, 2020. US Food & Drug Administration. “Coronavirus (COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection.”
  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-diagnostic-test-screening-people-without-known-or.
  Food & Drug Administration.