30 devices · GMDN 54335
Prolactin IVD kits using chemiluminescent immunoassay detect prolactin levels in blood or serum samples, helping diagnose conditions like hyperprolactinemia, infertility, or pituitary disorders. These assays provide quantitative or qualitative results by measuring hormone concentrations through light emission after a chemical reaction.
These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 510(k) clearance depending on the jurisdiction. They are usually supplied as reagent kits, including all necessary components for testing, and are intended for use in clinical laboratories or specialized medical settings.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.