DIRECTIGEN NEISSERIA MENINGITIDIS TEST

DIRECTIGEN NEISSERIA MENINGITIDIS TEST is an FDA 510(k)-cleared medical device (K920274) 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 17, 1992. Regulation: 8.