DIRECTIGEN MENNINGITIS TEST KIT

DIRECTIGEN MENNINGITIS TEST KIT is an FDA 510(k)-cleared medical device (K841308) 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 May 1, 1984. Regulation: 8.