555 devices · GMDN 55461
Multiple drugs of abuse IVD controls are laboratory reference materials designed to validate the accuracy and reliability of drug testing assays. They simulate positive or negative results for common substances like opioids, cocaine, or benzodiazepines in clinical specimens, ensuring test systems perform as intended before patient samples are analyzed.
These controls 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 often supplied as pre-measured kits or liquid controls, intended for use in accredited laboratories to maintain test integrity and regulatory adherence.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.