17-Hydroxyprogesterone IVD, kit, enzyme immunoassay (EIA)

This category includes diagnostic test kits designed to measure the level of 17-hydroxyprogesterone in patient samples such as blood or saliva. These kits use an enzyme immunoassay method to support the clinical evaluation of congenital adrenal hyperplasia, a disorder affecting hormone production in the adrenal glands.

Devices in this category are in vitro diagnostic medical devices composed of reagents and associated materials for laboratory use. They are intended for professional healthcare settings and are regulated based on their intended use for detecting a specific biomarker, without including any therapeutic or medicinal components.