17 devices · GMDN 57049
This category includes control materials used to verify the accuracy and reliability of laboratory tests that detect HER2 protein in patient samples. These controls help ensure that diagnostic assays for HER2— a biomarker important in guiding cancer treatment, particularly in breast and gastric cancers—are performing correctly before patient results are reported.
Such control materials are regulated as in vitro diagnostic (IVD) devices and are intended solely for quality assurance purposes. They do not contain therapeutic agents and are not used for direct patient testing, but rather to validate that the test system is functioning as expected according to the manufacturer’s specifications.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.