Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)

This category includes test kits designed to measure total human chorionic gonadotropin (hCG) in clinical specimens using an enzyme immunoassay method. These kits detect various forms of hCG, including intact hormone, nicked variants, and subunits, and are used to support pregnancy detection or assess risks such as miscarriage or Down syndrome.

Devices in this category are in vitro diagnostic (IVD) reagents and associated materials supplied as complete kits for laboratory use. They are regulated as IVD medical devices and intended for professional or point-of-care testing environments, with performance based on the EIA methodology described in their labeling.