51 devices · GMDN 55717
Opiate/opiate metabolite IVDs (in vitro diagnostics) in kit form use enzyme immunoassay (EIA) to detect opiates or their breakdown products in clinical samples like urine or blood. Clinically, these tests help monitor opioid use, screen for substance abuse, or confirm exposure in medical or forensic settings, providing rapid qualitative or semi-quantitative results.
These devices are typically regulated as diagnostic tests, often requiring validation for accuracy and performance before market authorization. They’re commonly supplied as ready-to-use kits with reagents, controls, and instructions, designed for laboratory or point-of-care use where compliance with testing protocols is essential.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.