293 devices · GMDN 53448
Apolipoprotein B (Apo B) IVD reagents are laboratory chemicals designed to work alongside in-vitro diagnostic (IVD) systems for measuring Apo B levels in blood samples. Clinically, these reagents help assess cardiovascular risk by quantifying the protein bound to low-density lipoproteins (LDL), aiding in lipid management and patient monitoring for conditions like atherosclerosis.
These reagents are typically regulated as part of IVD systems and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are usually supplied as kits or components for use in clinical laboratories, often classified under IVD regulations rather than as standalone medical devices.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.