Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)

This category includes in vitro diagnostic kits designed to detect one or more forms of 25-hydroxy Vitamin D in clinical specimens such as blood or serum. These kits use an enzyme immunoassay (EIA) method to measure Vitamin D levels, supporting clinical assessment of Vitamin D status for purposes such as evaluating deficiency, sufficiency, or excess.

Devices in this category are supplied as complete reagent kits containing all necessary components for testing and are intended for use in clinical laboratory settings. They are regulated as in vitro diagnostic medical devices, with their classification and conformity assessment based on the intended use and risk profile as defined by applicable regulatory frameworks.