Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

This category includes test kits designed to detect cocaine or its metabolites in clinical samples, such as urine or blood, using enzyme immunoassay (EIA) technology. Clinically, these devices help screen for cocaine use, aiding in addiction monitoring, workplace drug testing, or forensic investigations by providing rapid, qualitative or semi-quantitative results.

Devices in this category are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 510(k) clearance, depending on jurisdiction. They are usually sold as kits containing reagents, controls, and instructions for laboratory use, with performance validated for clinical specimen testing.