50 devices · GMDN 55570
Cocaine/cocaine metabolite IVD reagents are laboratory chemicals designed to work with parent immunoassay kits for detecting cocaine or its breakdown products in clinical samples. Clinically, these reagents help confirm drug use in urine, blood, or other specimens by enabling precise testing in medical, forensic, or workplace settings.
These reagents are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are usually supplied as part of a larger assay system, often sold separately from the primary test kit to allow flexibility in testing workflows.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.