22 devices · GMDN 57778
Immunohistochemistry protease reagent IVD refers to substances used to prepare tissue samples for immunohistochemical testing by breaking down proteins to expose antigenic sites. These reagents, which may include enzymes such as proteinase K or pepsin, are applied to biological tissues or clinical specimens to enable accurate detection of target antigens during laboratory analysis.
Devices in this category are regulated as in vitro diagnostic medical devices and are intended for use in laboratory settings to support diagnostic procedures. They are supplied as reagents or kits and are designed for single use in enzyme-mediated antigen retrieval processes, with regulatory requirements based on their role in diagnostic testing rather than therapeutic action.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.