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510(k) DEN200043

FilmArray Global Fever Panel by Biofire Defense, LLC — Product Code QMV

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 20, 2020
Date Received
June 26, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
Device Class
Class II
Regulation Number
866.3966
Review Panel
MI
Submission Type

A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.

Other clearances by Biofire Defense, LLC

  • K243822 — BioFire Warrior Panel; BioFire Warrior Panel Control Kit (March 12, 2025)
  • K213362 — BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the (March 22, 2023)
  • K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fe (October 20, 2022)
  • K221460 — BioFire COVID-19 Test 2 (July 25, 2022)
  • K211079 — BioFire COVID-19 Test 2 (November 1, 2021)
  • K202382 — FilmArray Global Fever Panel External Control Kit (November 20, 2020)
  • K170883 — FilmArray NGDS Warrior Panel (June 22, 2017)
  • DEN160048 — FilmArray NGDS Warrior Panel (February 14, 2017)

Other clearances for product code QMV

  • K243463 — BIOFIRE FILMARRAY Tropical Fever Panel (December 5, 2024)
  • K220870 — BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fe (October 20, 2022)