399 devices · GMDN 56917
Multiple CD cell marker IVDs with antibodies are laboratory tests designed to identify and quantify specific cell surface proteins (CD markers) in blood or tissue samples. Clinically, they help diagnose and monitor conditions like immunodeficiencies, cancers, and autoimmune disorders by measuring cell populations such as T-cells, B-cells, or natural killer cells.
These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are usually supplied as kits containing reagents, controls, and instructions for use, often requiring specialized laboratory equipment for processing.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.