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 |
|
| 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. |
||||
| Fact Sheets | ||||
|
||||
| Instructions for Use and Quick Guides | ||||
|
| Software Modules for BioFire COVID-19 Test – Version 1.1 | ||
|
| Technical Notes |
|
| BioFire COVID-19 Test Report Form |
| BioFire COVID-19 Test Report Form |
| Fact Sheets |
| Healthcare Provider (Downloads from fda.gov) |
| Patient (Downloads from fda.gov) |
| NGDS BT-E Assay Report Form |
|
| NGDS BT-E Report Form |
| 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 |
| Technical Notes |
| Interim Guidelines for Laboratory Verification of Performance of the BioFire® Global Fever Panel |
| Information Sheet |
| All BioFire Defense FilmArray Panels |
| FilmArray BioThreat Panel Quick Guide |
| Quick Guide |
| Software Module |
| BioThreat Panel v2.5 RUO Pouch Module Installation Guide for FilmArray 2.0 |
| FilmArray Global Fever Panel – RUO 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 |
| Technical Notes |
| FilmArray System Packaging Instructions Technical Note |
| 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 |
| There are no Customer Advisory Notices at this time. |
