
Scimedx Corp.
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SCIMEDX PHASE II PR3 IGG ANTIBODY EIA is an FDA 510(k)-cleared medical device (K010287) manufactured by Scimedx Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 15, 2001. Regulation: 8.