GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST is an FDA 510(k)-cleared medical device (K872628) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 1987. Regulation: 8.