247 devices · GMDN 55455
These devices are calibrators designed to provide standardized reference points for assays that detect multiple therapeutic drugs or drugs of abuse in clinical samples. They help ensure the accuracy and reliability of tests by simulating known concentrations of target substances, supporting precise qualitative or quantitative analysis in laboratory settings.
Calibrators in this category 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 part of a test kit or as standalone reagents, with classification varying by region—always verify local regulatory requirements before use.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.