LabCorp "Esoteric Testing" Use Rx Only
LabCorpCOVID-19RT-PCR test EUASummary1ACCELERATED EMERGENCY USE AUTHORIZATION(EUA)SUMMARYCOVID-19 RT-PCRTEST (LABORATORY CORPORATION OF AMERICA)For Invitro Diagnostic Use Rx Only For use under Emergency Use Authorization (EUA) only(The COVID-19 RT-PCR test (LabCorp Laboratory Test Number: 139900)will be performed at the Center for Esoteric Testing in Burlington, North Carolina, or other laboratories designated by Lab Corp that are also certified under the Clinical Laboratory Improvement Amendments of 1988(CLIA), 42 U.S.C.§263aas per Laboratory Instructions for Use that was reviewed by the FDA under this EUA.)