Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing

This category includes test kits designed for the detection of total human chorionic gonadotropin (hCG) in clinical specimens such as urine. These kits use an immunochromatographic test (ICT) format, commonly known as a lateral flow test, to provide rapid results for the qualitative or semi-quantitative measurement of hCG, which includes intact hCG, nicked forms, and subunits, to support pregnancy testing.

These devices are intended for self-testing by laypersons in non-clinical settings such as the home. They are supplied as complete kits containing all necessary reagents and materials, and are regulated as in vitro diagnostic (IVD) medical devices based on their intended use for detecting a biomarker associated with pregnancy.