13 devices · GMDN 53791
This category includes reagents used in laboratory tests to measure specific subclasses of immunoglobulin G (IgG) in patient samples. These reagents are designed to detect and quantify IgG subclasses such as IgG1, IgG2, IgG3, and IgG4, which play distinct roles in immune responses and are clinically relevant in diagnosing immunodeficiency, autoimmune disorders, and monitoring certain therapies.
As in vitro diagnostic (IVD) reagents, these substances are intended for use with compatible IVD instruments or systems to perform assays. They are supplied as standalone components that must be combined with other assay elements to generate a test result, and their regulatory status depends on the overall IVD system they support, with classification determined by the intended use and risk profile of the complete test.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.