PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST

PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST is an FDA 510(k)-cleared medical device (K984346) manufactured by Meridian Diagnostics, 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 24, 1999. Regulation: 8.