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Phoenix Biotech Corp.
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TREP-SURE TREPONEMAL ANTIBODY EIA is an FDA 510(k)-cleared medical device (K053570) manufactured by Phoenix Biotech Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2006. Regulation: 8.