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.

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.

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.

Updated: August 25, 2021

EUA No: EUA200044

• Healthcare Provider Fact Sheet (PDF, 269 KB)
• Patient Fact Sheet (PDF, 211 KB)

Determination and Declarations

Interim Order No. 314097

• BioFire COVID-19 Test Instructions for Use for Canada
  (Revision 1 – PDF, 1.9 MB)
• Quick Guide for BioFire COVID-19 Test
  (PDF, 1.2 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
(Link to canada.ca)

Kits Available

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

Software

Technical Notes

SDS

• Guidelines for Lab Verification of the BioFire COVID-19 Test Technical Note (PDF 197 KB)
• Biosafety when Testing Suspected SARS-CoV-2 Samples on the BioFire FilmArray System (PDF 37 KB)
• BioFire COVID-19 Test SARS-CoV-2 Reactivity (PDF 246 KB) Updated 12/08/21

BioFire COVID-19 Test
External Control Kit NHPS

Reporting