ORTHO DNA PROBE HSV CONFIRMATION TEST

ORTHO DNA PROBE HSV CONFIRMATION TEST is an FDA 510(k)-cleared medical device (K852360) 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 September 11, 1985. Regulation: 8.