Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)

This category includes test kits designed to detect methamphetamine in clinical samples such as urine or blood using an enzyme immunoassay method. These kits contain the necessary reagents and materials to perform the assay and are used to support diagnosis, monitoring, or screening for methamphetamine use in healthcare or toxicology settings.

Devices in this category are in vitro diagnostic medical tests that are regulated based on their intended use and risk profile. They are supplied as complete kits for laboratory use and are intended for professional handling, with performance characteristics established through validation rather than claims of approval or clearance.