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.
| US FDA Documentation – EUA
The FilmArray BioThreat-E test is for use only under Emergency Use Authorization (EUA) by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests and by clinical laboratory personnel that have been appropriately trained. |
| Fact Sheets |
| Instructions for Use and Quick Guides |
| Software Modules for FilmArray BioThreat-E Test |
| Technical Notes |
| FilmArray BioThreat-E Test 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 | ||||
| Instructions for Use and Quick Guides | ||||
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| 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) |
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| Technical Notes | ||||
| BioFire COVID-19 Test Report Form | ||||
| IVD – For in vitro Diagnostic Use Panel |
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| Instructions for Use and Quick Guides | ||||
| BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel Instructions for Use and Quick Guides | ||||
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| 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) |
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| Technical Notes | ||||
| IVD – For in vitro Diagnostic Use Panel | ||||
| Instructions for Use and Quick Guides | ||||
| BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel Instructions for Use and Quick Guides | ||||
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| 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) |
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| Technical Notes | ||||
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| Information Sheet |
| Not for Diagnostic Use Panel |
| Instructions for Use and Quick Guides |
| Not for Diagnostic Use Panel |
| Instructions for Use and Quick Guides |
| Software Module |
| Not for Diagnostic Use Panel |
| Instructions for Use and Quick Guides |
| Software Pouch Module |
| FilmArray Software Pouch Module Guide |
| LIS Connection Support |
| BioFire FilmArray LIS Connection Request Form |
| Software Technical Notes |
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BIOFIRE FILMARRAY 2.0 System Software (FSS) 2023 Update for G5 Laptops |
| 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 |
| FilmArray Addendum Manual |
| Addendum for the BioFire FilmArray 2.0 Operator’s Manual |
