27 devices · GMDN 60979
This category covers diagnostic test kits designed to measure estradiol (E2) levels in clinical samples using chemiluminescent immunoassay technology. These devices help clinicians assess hormone balance, monitor menopausal symptoms, evaluate infertility, and diagnose conditions like polycystic ovary syndrome (PCOS) or estrogen-related cancers.
Kits in this category are typically regulated as in vitro diagnostic (IVD) devices, often requiring compliance with standards for analytical performance and clinical safety. They are supplied as complete reagent systems for laboratory use, with classification varying by jurisdiction based on risk factors like intended use and potential patient impact.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.