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Illumina, Inc.
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ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II is an FDA 510(k)-cleared medical device (K093129) manufactured by Illumina, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 2010. Regulation: 8.