TINA-QUANT ALPHA-1 ANTITRYPSIN

TINA-QUANT ALPHA-1 ANTITRYPSIN is an FDA 510(k)-cleared medical device (K010978) manufactured by Rochdiag. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 2001. Regulation: 8.