21 devices · GMDN 41353
This category consists of control materials used to verify the accuracy and reliability of laboratory tests that measure total immunoglobulin G (IgG) in patient samples. These controls help ensure that diagnostic assays for IgG are functioning correctly by providing a known reference point for test performance.
Such devices are regulated as in vitro diagnostic (IVD) controls and are intended solely for quality assurance in laboratory testing. They are not diagnostic tools themselves and do not contain medicinal substances; their use is limited to validating the performance of IgG measurement assays.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.