BioFire® COVID-19 Test

Tests for Coronavirus (COVID-19) with results in about 45 minutes.

The BioFire® COVID-19 Test is a nested multiplexed RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in samples from individuals suspected of COVID-19 by their healthcare provider.

US FDA – BioFire COVID-19 Test v1.1

  • This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;

  • This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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.

Date of Issuance Letter of Authorization Fact Sheets and Labeling Determination and Declarations
Issued: March 23, 2020

Updated: May 24, 2022

EUA No: EUA200044

Authorization Letter (Link to Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19)
(Link to
BioFire COVID-19 Test – Version 1.1

IFU and Quick Guides Updated: May 2022

Kits Available
Part No. Kit Description
423744 BioFire COVID-19 Test v1.1 (30-pack)

Instructions for Use and Quick Guides are found in the table above

Part No. Kit Description


BIOFIRE® SHIELDControl Kit for the BioFire COVID-19 Test v1.1 (6 control vials)

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

Download the BioFire COVID-19 Test v1.1 Information Sheet
BioFire COVID-19 Test – Version 1.1
BioFire COVID-19 Software Pouch Module for v1.1 (Updated May 2022)

BioFire COVID-19 Test v1.1 ERM Software Download Form (Released September 2022)


Technical Notes
BioFire COVID-19 Test SDS Sheet

BIOFIRE® SHIELD Control Kit for COVID-19 Test

Please report adverse events associated with the use of the BioFire COVID-19 Test here: BioFire COVID-19 Test Report Form