Multiple Shigella species culture isolate antigen IVD, kit, agglutination

27 devices · GMDN 51600

This category includes in vitro diagnostic (IVD) kits designed to detect antigens from multiple Shigella species using agglutination tests. These devices rely on cultured clinical specimens to identify bacterial antigens, aiding in the diagnosis of shigellosis, a common cause of bacterial dysentery.

These kits are typically regulated as IVDs and may require compliance with standards like ISO 13485 or FDA 21 CFR Part 820, depending on the jurisdiction. They are generally supplied as pre-packaged reagent sets for laboratory use, requiring no additional medication or prescription.

This category summary is AI-generated from the GMDN nomenclature and has not been verified by a human reviewer.

Devices in this category