127 devices · GMDN 57771
Immunohistochemistry chromogenic substrate kits are diagnostic tools used in pathology labs to visually identify specific proteins or antigens in tissue samples. By reacting with antibodies bound to cellular markers, these kits help pathologists detect and analyze conditions like cancer, infections, or autoimmune diseases through stained tissue sections.
These kits are typically regulated as in vitro diagnostic (IVD) devices, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are commonly supplied as pre-packaged reagent sets, including substrates like DAB or AEC, and are used exclusively in clinical or research laboratory settings for precise diagnostic purposes.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.