DIRECTIGEN MENINGITIS COMBO TEST KIT

DIRECTIGEN MENINGITIS COMBO TEST KIT is an FDA 510(k)-cleared medical device (K915330) 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 March 22, 1992. Regulation: 8.