Device typeMultiple cell-mediated host immune response marker IVD, kit, rapid ICT, clinical: A 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.
FDA categoryLateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Device ID00850056728119
Catalog numberCP0517
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information