BD gains FDA clearance and CE mark for bacterial panels on COR System

The panels employ PCR techniques to test for numerous gastrointestinal bacterial pathogens using one stool swab.

Becton, Dickinson and Company (BD) has secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE marking under the European Union’s In Vitro Diagnostic Regulation (IVDR) for its bacterial panels for use on the BD COR System.

Employing polymerase chain reaction (PCR) techniques, the Enteric Bacterial Panel (EBP) and Enteric Bacterial Panel plus (EBP plus) panels test for numerous gastrointestinal (GI) bacterial pathogens using a single stool swab.

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