d042c6a5-f6e5-4bea-afe7-ccff22a29cfcNewPublished12020-12-212020-12-11In Commercial Distribution00856464008683PrimaryGS1HealthConfirmCOVIDRev061620806524968CONFIRM BIOSCIENCES, INC.1This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by Clinical Reference Laboratory, Inc. located in Lenexa, KS. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse64747SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.falseActivefalsefalse