38 devices · GMDN 50568
Borrelia burgdorferi IgG/IgM antibody IVD kits use enzyme immunoassay (EIA) technology to detect antibodies against the bacteria responsible for Lyme disease. These tests analyze clinical specimens to help diagnose infections by identifying immune responses (IgG for chronic exposure or past infection, IgM for acute infection).
These kits are typically regulated as in vitro diagnostic devices, with classification and supply varying by jurisdiction. They are designed for laboratory use and require proper training to perform and interpret results accurately. Availability may depend on local health authority requirements and clinical guidelines.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.