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FDA 510(k)

BioFire COVID-19 Test 2

K-Number: K221460 · 2022-07-25

ApplicantBiofire Defense, LLC
Decision Date2022-07-25
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 2022-07-25 under approval number K221460. 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 2022-07-25. It is manufactured by Biofire Defense, LLC. The 510(k) number is K221460.

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

BioFire COVID-19 Test 2 received FDA 510(k) clearance on 2022-07-25, under approval number K221460.

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 K211079BioFire COVID-19 Test 2 K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

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Related Devices (Code: QQX)

K211079BioFire COVID-19 Test 2Biofire Defense, LLC K213804cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsRoche Molecular Systems, Inc. K212147Simplexa COVID-19 DirectDiasorin Molecular, 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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