ELLUME·LAB ·lab Covid Antigen

For in vitro diagnosticuseonly.Forprescriptionuseonly.ThisproducthasnotbeenFDAclearedorapprovedbuthas

beenauthorizedbyFDAunder an EmergencyUseAuthorization (EUA) forusebyauthorizedlaboratories;useby

high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings

operating under a CLIA Certicate of Waiver, Certicate of Compliance, or Certicate of Accreditation. The

emergency use of this test product is only authorized for the duration of the declaration that circumstances exist

justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19

underSection564(b)(1)oftheAct,21U.S.C.§360bbb-3(b)(1),unlessthedeclarationisterminatedofauthorizationis

terminatedorrevokedsooner.ThetestproductisauthorizedonlyforthedetectionofproteinsfromSARS-CoV-2,not