85 devices · GMDN 52867
Multiple electrolyte IVD calibrators are reference materials designed to provide precise, standardized measurements for electrolyte assays. Clinically, they ensure accuracy in tests for sodium, potassium, chloride, and other electrolytes in patient specimens, helping to confirm diagnosis and monitor conditions like electrolyte imbalances or kidney dysfunction.
These calibrators are typically regulated as in vitro diagnostic (IVD) devices, often requiring compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are supplied as kits or solutions, often traceable to international reference standards, and may be classified based on their intended use and risk level in specific jurisdictions.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.