Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

This category includes in vitro diagnostic kits designed to measure total human chorionic gonadotropin (hCG) in clinical specimens using a chemiluminescent immunoassay method. These kits detect various forms of hCG, including intact, nicked, and subunit variants, and are used to support pregnancy detection and assess risks for adverse pregnancy outcomes such as miscarriage or trisomy 21.

Devices in this category are supplied as reagent kits containing all necessary components for testing and are intended for use with compatible laboratory analyzers. They are regulated as in vitro diagnostic medical devices and must meet applicable performance and safety requirements for clinical use, though specific regulatory classifications vary by jurisdiction and are not assigned at the category level.