ORTHO VARICELLA-ZOSTER VIRUS IDENT.

ORTHO VARICELLA-ZOSTER VIRUS IDENT. is an FDA 510(k)-cleared medical device (K841526) 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 24, 1984. Regulation: 8.