BioFire COVID-19 Test 2

Respiratory Specimen Nucleic Acid Sars-cov-2 Test

BioFire Defense, LLC

The following data is part of a premarket notification filed by Biofire Defense, Llc with the FDA for Biofire Covid-19 Test 2.

Pre-market Notification Details

Device IDK211079
510k NumberK211079
Device Name:BioFire COVID-19 Test 2
ClassificationRespiratory Specimen Nucleic Acid Sars-cov-2 Test
Applicant BioFire Defense, LLC 79 W 4500 S, Suite 14 Salt Lake City,  UT  84107
ContactCynthia Phillips
Product CodeQQX  
CFR Regulation Number866.3981 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-12
Decision Date2021-11-01
Summary:summary

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