31 devices · GMDN 53074
Total lactate dehydrogenase (LDH) IVD reagents are chemical substances designed to work with in vitro diagnostic (IVD) systems for measuring LDH levels in blood or other clinical samples. These reagents enable laboratories to quantify LDH, a key enzyme used as a biomarker for tissue damage, infection, or certain diseases like hemolytic anemia or liver disorders.
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 laboratory use, requiring proper handling and calibration to ensure accurate diagnostic results.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.