Device typeTreponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
FDA categoryAntigens, Ha, Treponema Pallidum
Device ID00850212007010
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
SizeSize Type = Tests per Kit; Size Unit = 100; Unit of Measure = Tests