K211079

Substantially Equivalent

BioFire COVID-19 Test 2

Applicant: Biofire Defense, LLC
Product code: QQX
Advisory panel: Microbiology
Date received: 2021-04-12
Decision date: 2021-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.