Meridian Bioscience Requests 510(k) Clearance for Campylobacter Assay
Meridian Biosciences has filed a 510(k) submission with the FDA for its Curian Campy assay, a rapid test for detecting the presence of Campylobacter spp. in human stool samples.
The qualitative fluorescent immunoassay is intended for use in detecting the gram-negative bacteria that causes campylobacteriosis. It is run on the company’s Curian Analyzer system.
Campylobacteriosis is a common bacterial infection in humans that is often transmitted through food. Patients usually recover from the infection on their own, but some may require antibiotics, according to the Centers for Disease Control and Prevention.