46 devices · GMDN 53395
Low-density lipoprotein (LDL) cholesterol IVD kits with spectrophotometry are laboratory tools designed to measure LDL cholesterol levels in blood samples. Clinically, these devices help assess cardiovascular risk by quantifying LDL—a key factor in plaque buildup and atherosclerosis—supporting diagnosis and treatment planning for conditions like hyperlipidemia.
These kits typically include reagents, controls, and instructions for use, regulated as in vitro diagnostics (IVDs) under global standards like IVDR (EU) or FDA (US). Classification varies by jurisdiction, but they’re generally considered high-risk due to their role in patient risk stratification. Supply chains often involve medical laboratories or point-of-care settings with spectrophotometric analyzers.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.