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)

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 Updated: August 2021; Quick Guides Updated: May 2021 

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

IFU Updated: February 2021; Quick Guide Updated: June 2021

Software Modules for BioFire COVID-19 Test – Version 1.1
BioFire COVID-19 Test Pouch Module Installation Instructions
BioFire COVID-19 Test v 1.1 Pouch Module Download Form
Technical Notes
BioFire COVID-19 Test Report Form
BioFire COVID-19 Test Report Form

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

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

Medical Device Advisory Notice: Pouch Module Software Update

 

Customer Acknowledgement of Receipt Form

Additional Support Documents

Safety Data Sheets

Product Warranty Documents