16 devices · GMDN 52931
Alkaline phosphatase (ALP) isoenzyme IVD reagents are substances or reactants designed to be used with a parent in vitro diagnostic device to enable the quantitative measurement of specific ALP isoenzymes in clinical specimens such as serum or plasma. These reagents support laboratory testing that helps assess liver, bone, or other tissue-related conditions by measuring different forms of the ALP enzyme.
As components of in vitro diagnostic systems, these reagents are intended for use only in conjunction with their corresponding parent IVD assay and are not standalone tests. Their regulation follows the rules for IVD reagents, meaning they are subject to the same regulatory framework as the assay they support, including requirements for performance, safety, and suitability for their intended use in clinical laboratories.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.