DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM

DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM is an FDA 510(k)-cleared medical device (K981306) manufactured by Diamedix Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 1998. Regulation: 8.