42 devices · GMDN 56948
CD15 cell marker IVDs are in vitro diagnostic tests designed to detect the presence or measure levels of the CD15 antigen in biological samples, such as tissue or blood. Clinically, these tests support the diagnosis and monitoring of conditions like leukemia, lymphoma, and other hematologic disorders by identifying cells expressing this marker.
These devices are typically regulated as in vitro diagnostics, with classification and supply depending on their intended use and risk level. They are often supplied as reagents, kits, or ready-to-use solutions for laboratory use, adhering to strict manufacturing and performance standards to ensure accuracy and reliability in clinical settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.