45 devices · GMDN 60094
Exogenous DNA/RNA internal control IVD kits are diagnostic tools designed to validate molecular testing processes. They contain synthetic nucleic acids added to clinical samples to confirm that DNA or RNA extraction and amplification are working correctly, or to detect potential inhibitors that could interfere with test results.
These kits are typically regulated as in vitro diagnostics (IVDs) and are supplied as part of a molecular assay workflow. They are used in laboratories to ensure assay reliability and accuracy before interpreting patient test results, though they do not contain or deliver therapeutic agents.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.