Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic test kits designed to detect immunoglobulin M (IgM) antibodies specific to Borrelia burgdorferi in patient specimens. These kits use an enzyme immunoassay (EIA) method to support the clinical assessment of recent or active infection with the bacterium that causes Lyme disease.

Devices in this category are intended for use in clinical laboratories and are regulated as in vitro diagnostic medical devices. They are supplied as complete reagent systems and are not intended for standalone use without appropriate instrumentation and procedural controls.