20 devices · GMDN 55132
This category includes in vitro diagnostic (IVD) kits designed to detect anti-SSB or anti-La antibodies, also known as Sjogren's antibodies, in patient specimens such as serum or plasma. These tests use an enzyme immunoassay (EIA) method to support the clinical assessment of autoimmune conditions, particularly Sjogren's syndrome, by identifying specific autoantibodies associated with the disease.
Devices in this category are supplied as complete reagent kits containing all necessary components for performing the assay and are regulated as IVD medical devices. They are intended for use by trained laboratory professionals in clinical settings and must comply with applicable IVD regulatory requirements for performance, safety, and labeling in the jurisdictions where they are marketed.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.