19 devices · GMDN 60740
A home-use blood glucose spot-check system is a portable, electrically powered device assembly designed for individuals with diabetes to manually measure and display their blood glucose levels on demand. It is intended for occasional, user-initiated testing rather than continuous monitoring and includes a glucose meter, test strips, lancets, control solutions, and related components, with some versions incorporating noninvasive measurement technology calibrated using blood specimens.
This category of device is intended for use by laypersons in the home environment, though certain models may also be suitable for point-of-care settings. As a medical device, it falls under regulatory oversight for in vitro diagnostic devices, with specific requirements for performance, safety, and labeling based on its intended use and mechanism of action, though classification varies by jurisdiction.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.