HERPES GROUP IGG ELISA TEST SYSTEM

HERPES GROUP IGG ELISA TEST SYSTEM is an FDA 510(k)-cleared medical device (K963645) manufactured by Armkel, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 1997. Regulation: 8.