Dxna, LLC
GeneSTAT.MDx Coccidioides Assay
SKU DEN170041UPC QAA
In Stock
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IIFDA 510(k) Cleared (DEN170041)
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Dxna, LLC
Free shipping on orders over $99 · 30-day returns
GeneSTAT.MDx Coccidioides Assay is an FDA 510(k)-cleared medical device (DEN170041) manufactured by Dxna, LLC. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 28, 2017. Regulation: 8.
