26 devices · GMDN 53785
Total immunoglobulin G (IgG total) IVD kits using nephelometry or turbidimetry measure antibody levels in blood or cerebrospinal fluid to diagnose immune deficiencies, infections, or autoimmune disorders. These tests help clinicians assess patient immune function by quantifying IgG concentrations, aiding in conditions like common variable immunodeficiency or chronic infections.
These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 510(k) clearance depending on jurisdiction. They are usually supplied as reagent cartridges or kits for use in laboratory analyzers, requiring proper calibration and maintenance to ensure accurate IgG measurement.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.