Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

This category includes diagnostic test kits designed to detect amphetamine and methamphetamine in clinical specimens using enzyme immunoassay (EIA) technology. These devices provide qualitative or quantitative results to aid in identifying drug presence, often used in toxicology, forensic, or clinical settings to monitor substance use or exposure.

These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards for analytical performance, safety, and labeling. They are usually supplied as ready-to-use reagents or components requiring assembly, with classification varying by jurisdiction based on risk and intended use.