76 devices · GMDN 57338
Ki67 antigen in vitro diagnostic (IVD) antibodies are laboratory tools designed to detect the Ki67 protein, a marker used to assess cell proliferation in tissue samples. Clinically, these devices help diagnose and monitor conditions like cancer by identifying actively dividing cells, aiding in prognosis and treatment planning.
These antibodies are typically regulated as IVD reagents, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They’re commonly supplied as kits or reagents for use in immunohistochemistry (IHC) or flow cytometry, with classification varying 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.