Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid

This category includes test kits designed to detect the beta-subunit of human chorionic gonadotropin (beta-HCG) in clinical specimens such as urine or serum. These immunochromatographic tests provide rapid qualitative or semi-quantitative results, commonly used to support pregnancy detection or monitor certain medical conditions where HCG levels are clinically relevant.

Devices in this category are in vitro diagnostic (IVD) products supplied as complete kits containing all necessary reagents and materials for testing. They are intended for use in laboratory or point-of-care settings and are regulated based on their intended use and risk profile, with individual devices subject to conformity assessment under applicable IVD regulations.