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Third Wave Technologies, Inc.
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INVADER UGT1A1 MOLECULAR ASSAY is an FDA 510(k)-cleared medical device (K051824) manufactured by Third Wave Technologies, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 17, 2005. Regulation: 8.