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 Defense, LLC

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories5
Latest Approval2025-03-12
TypeNumberDevice NameCodeDate
510(k) K243822 BioFire Warrior Panel; BioFire Warrior Panel Control Kit PRD 2025-03-12 View
510(k) K213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel QVR 2023-03-22 View
510(k) K220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel QMV 2022-10-20 View
510(k) K221460 BioFire COVID-19 Test 2 QQX 2022-07-25 View
510(k) K211079 BioFire COVID-19 Test 2 QQX 2021-11-01 View
510(k) DEN200043 FilmArray Global Fever Panel QMV 2020-11-20 View
510(k) K202382 FilmArray Global Fever Panel External Control Kit PMN 2020-11-20 View
510(k) K170883 FilmArray NGDS Warrior Panel PRD 2017-06-22 View
510(k) DEN160048 FilmArray NGDS Warrior Panel PRD 2017-02-14 View
↑