855ebf4a-a959-4fd1-b1ba-0652319cd4c3NewPublished12026-05-052026-04-27In Commercial Distribution00850056728126PrimaryGS1FebriDx® Bacterial / Non-Bacterial AssayCP0014CP0014081135788Lumos Diagnostics, Inc.1FebriDx® Bacterial / Non-Bacterial Assay Test Kit, 25 testsfalsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-855-586-6739info@lumosdiagnostics.comK26078700064042Multiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple cell-mediated (i.e., non-immunoglobulin) host immune response markers of bacterial and/or viral infection in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to differentiate bacterial from viral infection, and/or to predict patient outcomes by grading disease severity. It is not intended to be used for self-testing.falseActiveQXALateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory InfectionStorage Environment TemperatureHandling Environment Humidityfalsefalse