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 |
| 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 Forms |
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| BioThreat-E Report Form | NGDS BT-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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| Instructions for Use and Quick Guides | ||||||||||||
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| Health Canada Documentation | ||||||||||||
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| Software Modules | ||||||
| BioFire COVID-19 Test Pouch Module Installation Instructions | ||||||
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| Technical Notes |
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| BioFire COVID-19 Test Report Form |
| BioFire COVID-19 Test 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 1.5 |
| 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 |
| Technical Notes |
| FilmArray System Packaging Instructions Technical Note |
| Advisory Notice: Bordetella pertussis |
| 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 |
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Increased risk of false negative Adenovirus results using BioFire® FilmArray® Pneumonia (PN) Panel (Part No: RFIT-ASY-0144 and RFIT-ASY-0145) within 6 months of expiration.
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Customer Acknowledgement of Receipt Form |
| FilmArray® BioThreat v2.5 Panels (P/N RFIT-ASY-0094, Lot 309621D) Short-dated Expiration Date on Outer Box and Pouch Mylar Bag Labels | Customer Acknowledgement of Receipt Form |
| BioFire® COVID-19 Test Kits (Kit 423744, Label DFA2-LBL-0058, Lot 311221D) Short-dated Expiration Date on Outer Box Label | Customer Acknowledgement of Receipt Form |
| Increased risk of false positive Pseudomonas aeruginosa results using BioFire® FilmArray® Blood Culture Identification (BCID) Panel (Part No.: RFIT-ASY-0126 and RFIT-ASY-0127) and BioFire® Blood Culture Identification 2 (BCID2) Panel Part No.: RFIT-ASY-0147) with BD BACTEC™ blood culture vials | Customer Acknowledgement of Receipt Form |
| FilmArray® NGDS Warrior Panel Kits (Part Number: NGDS-ASY-0007) labeled with an Outdated Unique Device Identification (UDI) on the Outer Box Label | Customer Acknowledgement of Receipt Form |
