BioFire® FilmArray® Support –
Product Labeling

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.

Emergency Use Authorizations - Product Labeling

FilmArray BioThreat-E Test (EUA)

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

BioFire COVID-19 Test (EUA)

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
BioFire COVID-19 Test – Version 1.1

IFU and Quick Guides Updated: May 2022

BIOFIRE® SHIELD™ Control Kit for the BioFire COVID-19 Test v1.1

IFU Updated: May 2022; Quick Guide Updated: June 2021 

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
BioFire COVID-19 Test Report Form
BioFire COVID-19 Test Report Form

NGDS BT-E Assay (EUA)

IVD - For in vitro Diagnostic Use Panels - Product Labeling

BioFire Global Fever Panel

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

Not for Diagnostic Use Panels - Product Labeling

BioFire Defense FilmArray Panels

BioThreat Panel

FilmArray BioThreat Panel Quick Guide
Quick Guide
Software Module
BioThreat Panel v2.5 RUO Pouch Module Installation Guide for FilmArray 2.0

Global Fever Panel - RUO

FilmArray Global Fever Panel – RUO Instructions for Use and Quick Guides
Instructions for Use
Quick Guide

Customer Advisory Notice

FilmArray Panels

There are no Customer Advisory Notices at this time.

Additional Support Documents

Safety Data Sheets

Product Warranty Documents