Alpha-fetoprotein (AFP) IVD, antibody

35 devices · GMDN 56770

Alpha-fetoprotein (AFP) antibody in vitro diagnostic (IVD) devices are laboratory reagents designed to detect the presence or measure levels of AFP, a protein linked to certain liver conditions, cancers, and fetal development disorders. Clinically, these tests help diagnose or monitor diseases like hepatocellular carcinoma, germ cell tumors, and non-cancerous liver conditions by analyzing blood or tissue samples.

These devices are typically regulated as IVDs, with classification and supply depending on their intended use—whether qualitative (detection only) or quantitative (measurement). They are commonly supplied as ready-to-use reagents, kits, or components for immunohistochemistry (IHC) or immunoassays, ensuring compatibility with laboratory workflows and diagnostic protocols.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category