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Biofire Diagnostics, LLC (Biomerieux)

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest FDA decision2024-12-05
TypeNumberDevice NameCodeDateActions
510(k) K243463 BIOFIRE FILMARRAY Tropical Fever PanelQMV2024-12-05 View
510(k) K243222 BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)QDS2024-11-06 View
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