130 devices · GMDN 65454
SARS-CoV-2 antigen rapid tests (self-testing) are portable diagnostic kits designed to detect viral proteins from COVID-19 in a sample, such as a nasal swab, within minutes. These immunochromatographic tests (ICTs) provide quick results for individuals to use at home or in non-clinical settings, helping identify active infections early.
These devices are typically regulated as in vitro diagnostics (IVDs) and may require compliance with performance standards, manufacturing quality controls, and labeling requirements. Availability varies by region, with some markets requiring prescription status or professional supervision, while others allow over-the-counter purchase for self-administration.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.