25 devices · GMDN 61864
An automated or semi-automated cell morphology analyser IVD is a laboratory instrument that uses microscopy, digital imaging, and software to capture and evaluate the shape, structure, and characteristics of cells in clinical specimens. It is used to support diagnostic assessments by enabling detailed visual analysis of blood, tissue, or other biological samples at the microscopic level.
Such devices are regulated as in vitro diagnostic medical devices and are typically supplied as integrated systems combining optical hardware, imaging sensors, and analytical software. They require appropriate validation and conformity assessment under IVD regulations, with classification depending on the intended use and associated risk in the jurisdiction of sale.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.