The BioFire® COVID-19 Test is a nested multiplexed RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider.
US FDA
Health Canada
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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. |
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March 23, 2020
EUA No: EUA200044 |
Authorization Letter (PDF, 257 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19) |
Health Canada Documentation | |||
May 4, 2020
Interim Order No. 314097 |
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Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 |
Software
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BioFire COVID-19 Software Pouch Module |
Kits Available |
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Quick Guide for BioFire COVID-19 Test (PDF, 1.2 MB) | Quick Guide for BioFire COVID-19 External Control Kit (PDF, 1.1 MB) | ||||||||||
Download the BioFire COVID-19 Test Kit Information Sheet |
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 |
Click Here for BioFire Diagnostic Clinical Customers