ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION

ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION is an FDA 510(k)-cleared medical device (K925208) 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 27, 1992. Regulation: 8.