1,513 devices · GMDN 57767
Immunohistochemistry antibody detection kits use enzyme-based techniques to identify specific proteins or cellular markers in tissue samples. Clinically, these devices help diagnose diseases like cancer by revealing the presence and distribution of antigens in biopsy specimens, aiding pathologists in precision medicine decisions.
These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards for analytical performance, safety, and labeling. They are usually supplied as complete reagent systems, requiring minimal additional equipment for use in pathology labs, though classification varies by jurisdiction based on risk and intended use.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.