Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Cannabinoid/cannabinoid metabolite IVDs (in vitro diagnostics) in this category are laboratory test kits designed to detect the presence or measure levels of cannabinoids—such as THC or its metabolites—in clinical samples like blood, urine, or oral fluid. These enzyme immunoassay (EIA) kits help clinicians assess recent or chronic cannabis exposure, supporting applications in drug testing, forensic analysis, or patient monitoring for substance use disorders.

These devices are typically regulated as diagnostic tests, often requiring validation for accuracy, precision, and compliance with standards like ISO 15189 or jurisdiction-specific IVD regulations. They are supplied as reagent kits, including antibodies, enzymes, and calibration standards, and are used exclusively in professional laboratory settings. Classification varies by region, but they are generally considered higher-risk due to their role in patient diagnosis or legal contexts.