116 devices · GMDN 65250
Preferentially expressed antigen in melanoma (PRAME) IVD antibody devices are laboratory tests designed to detect the presence of PRAME protein in clinical samples. Clinically, these tests support the diagnosis or monitoring of melanoma and other cancers where PRAME expression may be relevant, helping guide treatment decisions or assess disease progression.
These devices are typically in-vitro diagnostics (IVDs) regulated as medical devices rather than drugs. They are supplied as reagents or kits for use in clinical laboratories, often requiring validation for accuracy and reliability before deployment. Compliance with regulatory standards ensures their performance meets diagnostic needs in oncology settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.