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BD Secures the US FDA’s 510(k) Clearance and European CE-IVDR Certification for Enteric Bacterial Panels (EBP) on the BD COR System

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  • BD has received 510(k) clearance & CE Mark for its EBP & EBP plus panels on the BD COR System to detect gastrointestinal bacterial pathogens from a single stool swab using PCR-based testing
  • EBP detects multiple enteric bacterial pathogens, incl. Salmonella, Campylobacter (jejuni, coli), Shigella/Enteroinvasive E. coli, & Shiga toxin-producing E. coli, while EBP plus adds Enterotoxigenic E. coli, heat-labile & stable enterotoxin genes, Vibrio, Yersinia enterocolitica, & Plesiomonas shigelloides for broader pathogen coverage
  • BD COR System automates laboratory workflows with capacity for ~1,650 tests & ~1,000 results in 24hrs., offering 7hrs walk-away time & 15min. loading to enhance lab efficiency

Ref: PRNewsWire | Image: BD | Press Release

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