Device typeBorrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Borrelia burgdorferi in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Borrelia burgdorferi, the bacteria associated with Lyme disease.
FDA categoryAntigen, Treponema Pallidum For Fta-Abs Test, Extractable Antinuclear Antibody, Antigen And Control, Reagent, Borrelia Serological Reagent
Device ID05391516747646
Catalog number40-2017
Single useYes
MRI safetyLabeling does not contain MRI Safety Information