Ferritin IVD, kit, chemiluminescent immunoassay

26 devices · GMDN 61078

Ferritin IVD kits with chemiluminescent immunoassay are laboratory diagnostic tools designed to measure ferritin levels in blood or serum samples. Ferritin is a protein that stores iron in the body, and its levels are clinically important for diagnosing iron deficiency, iron overload disorders (like hemochromatosis), and monitoring conditions such as anemia or chronic diseases.

These kits typically include reagents, controls, and disposable components for use in automated or semi-automated immunoassay analyzers. Regulation varies by jurisdiction, but they are generally classified as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 510(k) clearance, depending on the intended use and risk level. Availability depends on local market approvals and healthcare provider preferences.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category