K-number	K211079
Device name	BioFire COVID-19 Test 2
Applicant	Biofire Defense, LLC
Product code	QQX
Device class	Class II
Decision date	Nov 1, 2021
Decision	Substantially Equivalent
Regulation	866.3981

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Source

View the full FDA submission: accessdata.fda.gov

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BioFire COVID-19 Test 2

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