FilmArray Support
Emergency Use Authorizations - Product Labeling
Fact Sheets
Instructions for Use and Quick Guides
Software Modules for FilmArray BioThreat-E Test
Technical Notes
Fact Sheets
Instructions for Use and Quick Guides
BioFire COVID-19 Test — Version 1.1
- BioFire COVID-19 Test v1.1 Instructions for Use (IFU)
- Quick Guide for BioFire COVID-19 Test v1.1 for Upper Respiratroy or Saliva Testing
- Quick Guide for BioFire COVID-19 Test v1.1 for Lower Respiratory Testing
BioFire® Shield™ Control Kit for the BioFire COVID-19 Test v1.1
- BIOFIRE SHIELD Control Kit Instructions for use for the BioFire COVID-19 Test v1.1
- Quick Guide BIOFIRE SHIELD Control Kit for the BioFire COVID-19 Test v1.1
Software Modules for BioFire COVID-19 Test — Version 1.1
- BioFire COVID-19 Test v 1.1 Pouch Module Download Form (Updated May 2022)
- BioFire COVID-19 Test v1.1 ERM Software Download Form (Released September 2022)
Technical Notes
IVD - For in vitro Diagnostic Use Panels - Product Labeling
Instructions for Use and Quick Guides
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel Instructions for Use and Quick Guides
For Kits expiring in 2025
For Kits expiring after 2025
Software
- BioFire Global Fever Panel – IVD Software Pouch Module for v2.1 (2.1.0.10B)
- BioFire Global Fever Panel ERM Software Download Form (v2.1.0.35)
Technical Notes
Instructions for Use and Quick Guides
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel Instructions for Use and Quick Guides
For Kits expiring in 2025
For Kits expiring after 2025
Software
- BioFire Global Fever Special Pathogens Panel Software Pouch Module for v1.0 (2.1.0.10B)
- BioFire Global Fever Special Pathogens Panel ERM Software Download Form (v1.0)
Technical Notes
Not for Diagnostic Use Panels - Product Labeling
Information Sheet
Instructions for Use and Quick Guides
Instructions for Use and Quick Guides
Software Module
Instructions for Use and Quick Guides
FILMARRAY System - Product Labeling
Software Pouch Module
LIS Connections Support
Software Technical Notes
E-Document Center (Redirects to BioFire Diagnostics)
- BIOFIRE FILMARRAY Operator’s Manual
- BIOFIRE FILMARRAY TORCH Operator’s Manual
- BIOFIRE FILMARRAY IVD Instructions for Use and System Documents