BioFire® COVID-19 Test – BioFire Defense

This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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

Date of Issuance	Letter of Authorization	Fact Sheets and Labeling	Determination and Declarations
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.
March 23, 2020 EUA No: EUA200044	Authorization Letter (PDF, 257 KB)	Healthcare Provider Fact Sheet* (PDF, 211 KB) Patient Fact Sheet* (PDF, 160 KB) BioFire COVID-19 Test Instructions for Use* (Revision 4 – PDF, 3.4 MB) *Updated – New Revision	Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19)
Health Canada Documentation
May 4, 2020 Interim Order No. 314097		BioFire COVID-19 Test Instructions for Use (Revision 1 – PDF, 2 MB) This IFU is for Canadian customers only	Interim order respecting the importation and sale of medical devices for use in relation to COVID-19

Part No.	Kit Description
423748	BioFire COVID-19 Test External Control kit (6 positive control vials)

External Controls	Reporting
BioFire Defense also developed an External Control Kit for the BioFire COVID-19 Test. Information for the External Control Kit is combined in the BioFire COVID-19 Test Instructions for Use and in this Quick Guide for BioFire COVID-19 External Control Kit (+).	Please report adverse events associated with the use of the BioFire COVID-19 Test here: COVID-19 Test Report Form

BioFire^® COVID-19 Test