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Biofire Diagnostics, LLC (Biomerieux)

FDA Regulatory Profile

Biofire Diagnostics, LLC (Biomerieux) appears in FDA public data with 0 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on December 5, 2024.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243463BIOFIRE FILMARRAY Tropical Fever PanelDecember 5, 2024
K243222BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel pNovember 6, 2024

FDA data resources