36 devices · GMDN 54413
Free thyroxine (FT4) in vitro diagnostic (IVD) kits use chemiluminescent immunoassay technology to measure the unbound, biologically active form of thyroid hormone in patient samples. Clinically, these tests help diagnose and monitor thyroid disorders like hyperthyroidism or hypothyroidism by providing precise FT4 levels, distinguishing between total and free hormone availability.
These kits are typically regulated as IVDs and may require compliance with standards like ISO 13485 or FDA 510(k) clearance, depending on the jurisdiction. They are usually supplied as reagent kits containing all necessary components for testing, including calibrators, controls, and assay buffers, ensuring consistency and accuracy in laboratory settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.