Device typeSARS-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.
FDA categoryReagents, 2019-novel coronavirus nucleic acid
Device ID00884999049109
Catalog number09N77-095
Single useYes
MRI safetyLabeling does not contain MRI Safety Information