CULTURESET HSV ISOLATION & ID SYS

CULTURESET HSV ISOLATION & ID SYS is an FDA 510(k)-cleared medical device (K842216) 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 January 28, 1985. Regulation: 8.