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.

Instructions for Use and Quick Guides
BioFire COVID-19 Test – Version 1.0 BioFire COVID-19 Test – Version 1.1

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

IFU Updated: June 2021; Quick Guides Updated: May 2021 

BioFire COVID-19 Test External Control Kit for the BioFire COVID-19 Test v1.0   BIOFIRE® SHIELD™ Control Kit for the BioFire COVID-19 Test v1.1

Quick Guide Updated: June 2021 

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

Health Canada Documentation
Date of Issuance: May 4, 2020

Authorized for use in Canada in accordance with the Interim Order Respecting the Importation and Sale of Medical Devices in relation to COVID-19

Interim Order No. 314097

Software Modules
BioFire COVID-19 Test Pouch Module Installation Instructions
BioFire COVID-19 Test – Version 1.0 BioFire COVID-19 Test – Version 1.1
BioFire COVID-19 Test v 1.0 Pouch Module Download Form BioFire COVID-19 Test v 1.1 Pouch Module Download Form
Technical Notes
Biosafety when Testing Suspected SARS-CoV-2 Samples on the BioFire FilmArray System
Guidelines for Laboratory Verification of Performance of the BioFire COVID-19 Test

BioFire COVID-19 Test SARS-CoV-2 Reactivity

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

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

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. 


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

Additional Support Documents

Safety Data Sheets

Product Warranty Documents