Meridian Bioscience Gains 510(k) Clearance for Its Curian Campy Assay

Cincinnati, Ohio-based Meridian Bioscience has received 510(k) marketing clearance from the FDA for its Curian Campy assay. 

The rapid, qualitative fluorescent immunoassay is designed to detect Campylobacter-specific antigen, including C. jejuni, C. coli, C. upsaliensis and C. lari, in human fecal specimens.

Campylobacter gastrointestinal infection, also known as campylobacteriosis, is one of the most widespread infectious diseases worldwide.