Here you will find technical notes, references, manuals and other support items for the commercial BioFire FilmArray System and Panels. For DOD specific documents or if you do not find what you are looking for, please contact our Technical Support Team.
| FilmArray BioThreat-E Test (EUA) Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| Fact Sheets |
| Healthcare Provider |
| Patient |
| FilmArray BioThreat-E Test (EUA) Software Module |
| Pouch Module Installation Guide |
| Technical Notes |
| Guidelines for Laboratory Verification of Performance of the FilmArray BioThreat-E |
| Sources of External Control Materials for the FilmArray BioThreat-E Test |
| BioThreat-E Kit Report Form |
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| BioThreat-E Report Form |
| US FDA Documentation – EUA
The EUA (Emergency Use Authorization) for the BioFire COVID-19 Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for SARS-CoV-2 in-house, providing results in approximately one hour. |
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| Fact Sheets | ||||
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| Instructions for Use and Quick Guides | ||||
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| Software Modules for BioFire COVID-19 Test – Version 1.1 | ||
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| Technical Notes |
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| BioFire COVID-19 Test Report Form |
| BioFire COVID-19 Test Report Form |
| BioFire Global Fever Panel Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| 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) | ||
| BioFire Global Fever Special Pathogens Panel Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| 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 |
| Protocols for Laboratory Verification of Performance of the BioFire Global Fever Special Pathogens Panel Technical Note |
| Information Sheet |
| All BioFire Defense FilmArray Panels |
| FilmArray BioThreat Panel Quick Guide |
| Instructions for Use |
| Quick Guide |
| FilmArray Global Fever Panel – RUO Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| Software Module |
| FilmArray Global Fever Panel RUO v1.1 Pouch Module v2.1.1 Download Form (Updated December 2022) |
| FilmArray Food & Water Panel – Instructions for Use and Quick Guides |
| Instructions for Use |
| Quick Guide |
| Software Pouch Module |
| FilmArray Software Pouch Module Guide |
| LIS Connection Support |
| BioFire FilmArray LIS Connection Request Form |
| E-Document Center (Redirects to BioFire Diagnostics) |
| FilmArray Operator’s Manual |
| FilmArray Torch Operator’s Manual |
| FilmArray IVD Instructions for Use and System Documents |
| Certifications (Redirects to BioFire Diagnostics) |
| FilmArray Instrument – EC Declaration of Conformity |
| FilmArray 2.0 Instrument – EC Declaration of Conformity |
| FilmArray Torch – EC Declaration of Conformity |
| Continuing Medical Education Courses on the FilmArray |
| ADVISORY NOTICE URGENT: MEDICAL DEVICE RECALL (bioMérieux FSCA 5788-1)
Shifted Melting Temperature (Tm) Associated with Instrument Calibration on BIOFIRE® FILMARRAY® 2.0 (FLM2-ASY-0001 and FLM2-ASY-0001-W) and TORCH (HTFA-ASY-0003, HTFA-ASY-0003U, and HTFA-ASY-0003-W) |
Click to view Acknowledgment Form |
| ADVISORY NOTICE URGENT: MEDICAL DEVICE RECALL (bioMérieux FSCA FA-TWD-000007)
Increased Risk of False Positive Vibrio/Vibrio cholerae Results Associated with Remel Cary Blair Medium when used with the BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel (RFIT-ASY-0116 and RFIT-ASY-0104) |
Click to view Acknowledgment Form |
| ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION (bioMérieux FSCA 5761-2)
Increased Risk of Power Short with the BIOFIRE® FILMARRAY® TORCH System |
Click to view Acknowledgment Form |
| ADVISORY NOTICE URGENT: MEDICAL DEVICE RECALL (bioMérieux FSCA FA-TWD-000005)
Increased Risk of False Positive Serratia marcescens Results on the BIOFIRE® Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147) |
Click to view Acknowledgment Form |
