AGGLUTINOTEST-SYPHILIS

AGGLUTINOTEST-SYPHILIS is an FDA 510(k)-cleared medical device (K791457) manufactured by Volu Sol Medical Industries. 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 23, 1979. Regulation: 8.