28 devices · GMDN 54665
Total prostate-specific antigen (tPSA) immunoassay kits use chemiluminescent technology to measure PSA levels in blood or serum samples. Clinicians rely on these tests to help diagnose, monitor, or assess prostate cancer risk, benign prostatic hyperplasia, or treatment response in patients.
These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with performance standards or premarket review depending on jurisdiction. They are supplied as reagent kits or integrated systems, often requiring calibration and maintenance per manufacturer instructions.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.