27 devices · GMDN 53793
Total immunoglobulin M (IgM) IVD kits using nephelometry or turbidimetry measure antibody levels in blood or serum to help diagnose infections, autoimmune disorders, or immune system dysfunction. These tests are critical for identifying acute immune responses, monitoring conditions like hepatitis or Lyme disease, and assessing primary immunodeficiency.
These kits are typically regulated as in vitro diagnostic (IVD) devices, requiring compliance with standards for accuracy, safety, and performance. They are commonly supplied as reagent-based systems for use in clinical laboratories, often requiring specialized equipment like nephelometers for analysis. Classification and supply vary by jurisdiction but generally follow IVD-specific pathways.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.