
Biofire Diagnostics, LLC (Biomerieux)
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BIOFIRE FILMARRAY Tropical Fever Panel is an FDA 510(k)-cleared medical device (K243463) manufactured by Biofire Diagnostics, LLC (Biomerieux). This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 4, 2024. Regulation: 8.

ADC
SKU DX606933

MDF
SKU DX683863

3M Littmann
SKU DX771242

Welch Allyn
SKU DX297280