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BinaxNOW COVID-19/Flu A&B Combo Self Test
Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens
Details
Device typeMultiple-genus respiratory virus antigen IVD, kit, rapid ICT, self-testing: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple virus genera associated with respiratory disease in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment.
FDA categoryMulti-Analyte Respiratory Virus Antigen Detection Test
Device ID00811877012610
AvailabilityOver the counter
Single useYes
MRI safetyLabeling does not contain MRI Safety Information