55 devices · GMDN 54811
Multiple antinuclear antibody (ANA) screening IVD reagents are substances used with diagnostic devices to detect one or more antinuclear antibodies in patient samples, helping clinicians identify autoimmune conditions. These reagents enable qualitative and quantitative screening tests that are essential for diagnosing diseases like lupus and rheumatoid arthritis.
Devices in this category are typically supplied as reagents that work with parent in vitro diagnostic systems to perform specific assay functions. Regulatory requirements vary by jurisdiction, but these screening reagents are generally subject to regulatory oversight as part of the diagnostic testing process.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.