Tumour-associated glycoprotein-72 (TAG72) IVD, antibody

This category includes antibody-based in vitro diagnostic devices designed to detect tumour-associated glycoprotein-72 (TAG72) in clinical specimens such as blood or tissue samples. These devices use one or more immunoglobulins that specifically bind to TAG72 antigens to support the qualitative or quantitative assessment of this biomarker, which is associated with certain epithelial cancers.

Devices in this category are regulated as in vitro diagnostics and are intended for use in laboratory settings to aid in the clinical evaluation of patients with suspected or known malignancies. They are supplied as reagents or test kits and must conform to applicable IVD regulatory requirements for performance, safety, and intended use, without implying any specific classification or approval status.