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Barcode (UDI): 4049016027478
Catalog No: EI 2132-9601-L G
Product Type: Medical Device
GMDN: Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay (50538)
Regulation: 98/79/EC
Description: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin A (IgA), immunoglobulin G (IgG) and/or immunoglobulin M (IgM) antibodies to one or multiple species of Borrelia in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Borrelia bacteria which may include B. afzelii, B. burgdorferi and/or B. garinii that are associated with Lyme disease.