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 test 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 test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens;

  • The emergency use of this test 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. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Health Canada – BioFire COVID-19 Test v1.0

  • Authorized for use in Canada in accordance with the Interim Order Respecting the Importation and Sale of Medical Devices for use in relation to COVID-19.
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: March 12, 2021

EUA No: EUA200044

Authorization Letter (PDF,  257 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19)
BioFire COVID-19 Test – Version 1.0 (Revision 5) BioFire COVID-19 Test – Version 1.1 (Revision 1)
– Now Available
 
Health Canada Documentation
Date of Issuance Fact Sheets and Labeling

Determination and Declarations

Issued: May 4, 2020

Interim Order No. 314097

Interim order respecting the importation and sale of medical devices for use in relation to COVID-19

Kits Available
Part No. Kit Description
423745 BioFire COVID-19 Test v1.1 (6-pack)
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
423748 BioFire COVID-19 Test External Control Kit for the BioFire COVID-19 Test v1.0
(6 positive control vials)

424062

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

Download the BioFire COVID-19 Test Kit Information Sheet
Software
BioFire COVID-19 Test – Version 1.0 BioFire COVID-19 Test – Version 1.1
BioFire COVID-19 Software Pouch Module for v1.0 BioFire COVID-19 Software Pouch Module for v1.1
Technical Notes
SDS
BioFire® COVID-19 Test SDS Sheet

BioFire COVID-19 Test
External Control Kit NHPS

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

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