47 devices · GMDN 54809
Multiple antinuclear antibody (ANA) screening IVDs using enzyme immunoassay (EIA) detect autoimmune markers in patient samples, helping diagnose conditions like systemic lupus erythematosus (SLE) or other connective tissue disorders. These kits analyze serum or plasma for multiple ANA targets, providing qualitative or quantitative results to support clinical decision-making.
These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are generally supplied as kits containing reagents, controls, and instructions for use, often intended for laboratory use only.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.