Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

29 devices · GMDN 60922

Multiple form 25-hydroxy vitamin D in-vitro diagnostic (IVD) kits use chemiluminescent immunoassay technology to measure different forms of 25-hydroxy vitamin D in blood or serum samples. Clinically, these devices help assess vitamin D status, diagnose deficiencies, and monitor conditions like rickets, osteoporosis, or metabolic bone disorders by quantifying vitamin D levels accurately.

These kits are typically regulated as IVDs and may require compliance with standards like ISO 13485 or FDA 510(k) clearance, depending on the jurisdiction. They are generally supplied as reagent kits with instructions for use, requiring calibration and maintenance by trained laboratory personnel to ensure reliable results.

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

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