63 devices · GMDN 56701
A chemiluminescent immunoassay analyser IVD is an automated or semi-automated laboratory instrument that uses light-producing chemical reactions to detect and measure specific substances in patient samples such as blood or serum. It is designed for the qualitative or quantitative analysis of biomarkers including proteins, hormones, drugs, or microbial toxins through immunological reactions coupled with chemiluminescent detection.
These instruments are regulated as in vitro diagnostic medical devices and typically require integration with software for sample handling, data analysis, and result reporting. They are intended for use in clinical laboratories by trained personnel and are supplied as complete systems including reagents, calibrators, and quality control materials necessary for operation.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.