
Illumina, Inc.
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ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY is an FDA 510(k)-cleared medical device (K132750) manufactured by Illumina, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2013. Regulation: 8.