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Repromedix Corp.
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REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) is an FDA 510(k)-cleared medical device (K001607) manufactured by Repromedix Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 2000. Regulation: 8.