SeraQuest Herpes Type 1 Specific IgG

SeraQuest Herpes Type 1 Specific IgG is an FDA 510(k)-cleared medical device (K162276) manufactured by Quest International, 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 September 30, 2016. Regulation: 8.