27 devices · GMDN 50913
Escherichia coli antigen IVD kits using agglutination detect traces of E. coli bacteria in clinical samples or cultures. These tests help identify specific bacterial strains by mixing a specimen with antisera, causing visible clumping (agglutination) if the antigen is present, aiding in rapid diagnostic confirmation of infection.
These kits are typically regulated as in vitro diagnostics (IVDs) and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820. They are often sold as complete test systems, including reagents, controls, and instructions, and are used in laboratories or point-of-care settings for bacterial identification.
This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.