HERPES I.D. TM TEST

HERPES I.D. TM TEST is an FDA 510(k)-cleared medical device (K771445) manufactured by Hyland Therapeutic Div., Travenol Laboratories. 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 13, 1977. Regulation: 8.