LSTC Receives Emergency Use Authorization for Home Collection Testing
The Life Sciences Testing Center has received Emergency Use Authorization (EUA) from the FDA to distribute home collection kits for the detection of COVID-19. Have questions about the testing process or the purpose of the test? Click on the applicable fact sheet below to learn more about the LSTC’s home collection kits and the FDA’s EUA.
Disclaimer: This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratory. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
LSTC Receives Emergency Use Authorization for Home Collection Testing
The Life Sciences Testing Center has received Emergency Use Authorization (EUA) from the FDA to distribute home collection kits for the detection of COVID-19. Have questions about the testing process or the purpose of the test? Click on the applicable fact sheet below to learn more about the LSTC’s home collection kits and the FDA’s EUA.
Disclaimer: This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratory. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. 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. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.