Biofire Diagnostics, LLC
FilmArray 2.0 System
SKU K143178UPC NSU
In Stock
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IIFDA 510(k) Cleared (K143178)
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Free shipping on orders over $99 · 30-day returns
Biofire Diagnostics, LLC
Free shipping on orders over $99 · 30-day returns
FilmArray 2.0 System is an FDA 510(k)-cleared medical device (K143178) manufactured by Biofire Diagnostics, LLC. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2015. Regulation: 8.
