Helicobacter pylori antigen IVD, kit, rapid ICT, clinical

This category includes rapid diagnostic test kits designed to detect Helicobacter pylori antigens in clinical specimens such as stool or gastric samples. These tests use immunochromatographic technology to provide quick results, aiding in the diagnosis of H. pylori infection linked to conditions like gastritis and peptic ulcers, and are intended for use in laboratory or point-of-care settings by healthcare professionals.

Devices in this category are in vitro diagnostic medical devices that are supplied as kits containing all necessary reagents and materials for a single test event. They are regulated based on their intended use and risk profile, with classification determined by applicable regulatory frameworks in each jurisdiction, and are not intended for self-testing by lay users.