20 devices · GMDN 55160
This category includes diagnostic test kits designed to detect antibodies against the Sm/RNP antigen complex in patient samples. These kits use an enzyme immunoassay method to support the clinical assessment of autoimmune conditions, particularly systemic lupus erythematosus and related disorders.
Devices in this category are in vitro diagnostic reagents intended for use in laboratory settings. They are supplied as complete kits containing all necessary components for performing the test and are regulated based on their intended use and risk profile in the jurisdiction where they are marketed.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.