40 devices · GMDN 57073
Cytokeratin immunohistochemistry (IHC) kits are laboratory diagnostic tools designed to detect specific protein markers (cytokeratins) in tissue samples. Clinically, they help diagnose and classify cancers, particularly distinguishing between epithelial tumors and other tissue types by identifying cellular origins and subtypes.
These kits 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 pre-packaged reagent sets for use in pathology labs, often requiring validation for specific clinical applications before implementation.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.