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Bd Becton Dickinson Vacutainer Systems Preanalytic
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BD DIRECTIGEN FLU A+B is an FDA 510(k)-cleared medical device (K001364) manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 27, 2000. Regulation: 8.