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Medical Devices / Submissions and Approvals

FDA Clears BD’s Antibiotic-Resistant Bacteria Test

Nov. 1, 2019
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Becton, Dickinson and Check-Points Health were granted FDA 510(k) clearance by the FDA for a molecular screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs) using the BD MAX system.

The assay provides detection of the five most common carbapenemase genes directly from the patient specimen in approximately 2.5 hours, as compared to traditional methods that can take up to 24 hours to confirm a negative or longer for a final positive result.

Early detection of patients infected with the antibiotic-resistant organisms can help physicians target infection control measures.

The BD MAX portfolio also includes assays for gastrointestinal infections as well as reproductive and sexually transmitted infections.

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