VARELISA TG (THYROGLOBULIN) ANTIBODIES,

VARELISA TG (THYROGLOBULIN) ANTIBODIES, is an FDA 510(k)-cleared medical device (K003414) manufactured by Pharmacia & Upjohn Co.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 2000. Regulation: 8.