BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS

BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS is an FDA 510(k)-cleared medical device (K021057) manufactured by Brahms Diagnostica, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 16, 2002. Regulation: 8.