SeraQuest HSV Type 2 Specific IgG

SeraQuest HSV Type 2 Specific IgG is an FDA 510(k)-cleared medical device (K181514) 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 June 12, 2019. Regulation: 8.