ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM

ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM is an FDA 510(k)-cleared medical device (K072178) manufactured by Zeus Scientific, 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 May 29, 2008. Regulation: 8.