IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS

IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS is an FDA 510(k)-cleared medical device (K910499) manufactured by Vitek 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 April 30, 1991. Regulation: 8.