19 devices · GMDN 48446
This category includes diagnostic test kits designed to detect both HIV-1 and HIV-2 antigens and antibodies in human blood or other clinical specimens. These kits use a chemiluminescent immunoassay method to support the diagnosis of HIV infection, monitor disease status, and screen blood or organ donations.
Devices in this category are in vitro diagnostic (IVD) medical devices supplied as complete reagent kits. They are intended for use in clinical laboratories by trained professionals and are regulated based on their intended use and risk profile, with individual products subject to conformity assessment under applicable IVD regulations.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.