Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Biofire Diagnostics, LLC (Biomerieux)

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

Total Devices2
Categories2
Latest Approval2024-12-05
TypeNumberDevice NameCodeDate
510(k) K243463 BIOFIRE FILMARRAY Tropical Fever Panel QMV 2024-12-05 View
510(k) K243222 BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) QDS 2024-11-06 View
↑