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FDA 510(k)

BioFire COVID-19 Test 2

K-Number: K211079 · 2021-11-01

ApplicantBiofire Defense, LLC
Decision Date2021-11-01
Product CodeQQX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioFire COVID-19 Test 2 is a medical device manufactured by Biofire Defense, LLC. It received FDA 510(k) clearance on 2021-11-01 under approval number K211079. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioFire COVID-19 Test 2?

BioFire COVID-19 Test 2 is a medical device that received FDA 510(k) clearance on 2021-11-01. It is manufactured by Biofire Defense, LLC. The 510(k) number is K211079.

When was BioFire COVID-19 Test 2 approved by the FDA?

BioFire COVID-19 Test 2 received FDA 510(k) clearance on 2021-11-01, under approval number K211079.

What company makes BioFire COVID-19 Test 2?

BioFire COVID-19 Test 2 is manufactured by Biofire Defense, LLC.

What is the FDA product code for BioFire COVID-19 Test 2?

The FDA product code for BioFire COVID-19 Test 2 is QQX.

Other Devices by Biofire Defense, LLC

K170883FilmArray NGDS Warrior Panel DEN160048FilmArray NGDS Warrior Panel DEN200043FilmArray Global Fever Panel K202382FilmArray Global Fever Panel External Control Kit K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel K221460BioFire COVID-19 Test 2

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Related Devices (Code: QQX)

K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. K212147Simplexa COVID-19 DirectDiasorin Molecular, LLC K221460BioFire COVID-19 Test 2Biofire Defense, LLC K230440Xpert® Xpress CoV-2 plusCepheid® K231306cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsRoche Molecular Systems, Inc. K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott Molecular

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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