ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)

ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) is an FDA 510(k)-cleared medical device (K950217) manufactured by American Laboratory Products Co., Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 23, 1995. Regulation: 8.