Methadone IVD, kit, enzyme immunoassay (EIA)

25 devices · GMDN 55682

Methadone IVD kits using enzyme immunoassay (EIA) are laboratory tools designed to detect methadone in clinical specimens, such as blood or urine. Clinicians use these kits to confirm methadone presence, monitor treatment adherence, or investigate suspected drug exposure, often in addiction medicine or forensic settings.

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. They are sold as pre-packaged reagent kits, often including controls, calibrators, and assay plates, with performance validated for clinical use.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category