52 devices · GMDN 38177
Cytokeratin IVD controls are materials used to verify that laboratory tests designed to detect cytokeratin proteins in patient samples are working correctly. These controls help ensure the accuracy and reliability of assays that identify specific cytokeratin subtypes, which are important biomarkers in cancer and other disease diagnostics.
As in vitro diagnostic (IVD) controls, these products are regulated to support the proper use of cytokeratin assays but are not diagnostic themselves. They are typically supplied as stabilized preparations, such as control slides or solutions, and are intended for laboratory use only to validate test performance before or during patient sample analysis.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.