21 devices · GMDN 52989
This category includes reagents used in laboratory tests to detect creatine kinase (CK) isoenzymes in patient samples such as blood or serum. These reagents are essential components of in vitro diagnostic (IVD) assays that help assess tissue damage, particularly in cardiac or skeletal muscle, by measuring specific forms of the CK enzyme.
As reagents, these products are intended for use only with compatible IVD instruments or test systems and are not standalone diagnostic tools. Their regulation depends on the parent IVD assay they support, and they are supplied for professional use in clinical laboratories to enable accurate measurement of CK isoenzyme activity.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.