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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 the device name listed in this FDA 510(k) record. The listed applicant is Biofire Defense, LLC. It received FDA 510(k) clearance on 2021-11-01 under 510(k) 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. The listed applicant is Biofire Defense, LLC. The 510(k) number is K211079.

When did BioFire COVID-19 Test 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for BioFire COVID-19 Test 2?

The FDA 510(k) record lists Biofire Defense, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07221097Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel for the Detection of COVID-19 and Other CoronavirusesCOMPLETED

Other records listing Biofire Defense, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control KitK243822BioFire Warrior Panel; BioFire Warrior Panel Control KitK213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens PanelK220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever PanelK221460BioFire COVID-19 Test 2K202382FilmArray Global Fever Panel External Control Kit

View all 8 devices →

Related Devices (Code: QQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243396Aptima SARS-CoV-2 AssayHologic, Inc.K240867cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsRoche Molecular Systems, Inc.K242109Xpert® Xpress CoV-2 plus (XPRS-COV2-10)Cepheid®K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)Abbott MolecularK233453Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR KitLife Technologies CorporationK230440Xpert® Xpress CoV-2 plusCepheid®

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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