The Flowflex COVID-19 Antigen Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Negative results do not rule out SARS-CoV2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. FlowFlex COVID-19 Home Test, Each This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.