ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES

ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES is an FDA 510(k)-cleared medical device (K891382) 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 June 5, 1989. Regulation: 8.