26 devices · GMDN 56891
Cancer antigen 125 (CA125) IVD antibody devices are laboratory tests designed to detect the presence or measure levels of CA125, a protein linked to ovarian cancer and other gynecological conditions. Clinically, these tests aid in monitoring tumor progression, assessing treatment response, and identifying potential recurrence in patients with known cancer.
These devices are typically in vitro diagnostics (IVDs) regulated as medical devices, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are commonly supplied as kits for use in clinical laboratories, including reagents, controls, and instructions for qualitative or quantitative analysis of patient specimens like serum or plasma.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.