42 devices · GMDN 54475
Multiple form 25-hydroxy Vitamin D IVD controls are laboratory reference materials designed to validate the accuracy and reliability of assays that measure different types of 25-hydroxy vitamin D in patient samples. They help ensure test results are consistent and clinically actionable by simulating real-world specimen conditions during quality checks.
These controls 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 ready-to-use liquids or kits, commonly distributed by manufacturers to support diagnostic laboratories in maintaining test performance and regulatory adherence.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.