15 devices · GMDN 63066
This category includes antibodies designed to detect free (unbound) prostate specific antigen (fPSA) in clinical specimens. These immunoglobulins bind to specific antigenic determinants of fPSA isoforms, such as benign PSA, inactive/intact PSA, or proPSA, enabling qualitative or quantitative measurement in diagnostic testing.
Devices in this category are in vitro diagnostic (IVD) reagents used in laboratory settings to support prostate cancer risk assessment and monitoring. They are regulated as IVD medical devices and supplied for professional use in clinical laboratories, with regulatory requirements based on their intended use and risk profile.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.