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510(k) K213362

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel by Biofire Defense, LLC — Product Code QVR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2023
Date Received
October 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiplex Nucleic Acid Detection System For Biothreat Agents
Device Class
Class II
Regulation Number
866.4000
Review Panel
MI
Submission Type

A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens

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  • 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)
  • DEN200043 — FilmArray Global Fever Panel (November 20, 2020)
  • 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 QVR

  • K231336 — T2 Biothreat Panel (September 15, 2023)