DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST is an FDA 510(k)-cleared medical device (K893753) 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 October 15, 1989. Regulation: 8.