EQ-PRC LC WARFARIN GENOTYPING KIT

EQ-PRC LC WARFARIN GENOTYPING KIT is an FDA 510(k)-cleared medical device (K073071) manufactured by Trimgen Corporation. 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 February 5, 2009. Regulation: 8.