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FDA 510(k)

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

K-Number: K220870 · 2022-10-20

ApplicantBiofire Defense, LLC
Decision Date2022-10-20
Product CodeQMV
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel 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 2022-10-20 under 510(k) number K220870. The device is classified under product code QMV. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel?

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is Biofire Defense, LLC. The 510(k) number is K220870.

When did BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel receive FDA 510(k) clearance?

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel received FDA 510(k) clearance on 2022-10-20, under 510(k) number K220870.

Who is the listed applicant for BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel?

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 Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel?

The FDA product code for BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel is QMV.

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 PanelK221460BioFire COVID-19 Test 2K211079BioFire COVID-19 Test 2K202382FilmArray Global Fever Panel External Control Kit

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Related Devices (Code: QMV)

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.

K243463BIOFIRE FILMARRAY Tropical Fever PanelBiofire Diagnostics, LLC (Biomerieux)

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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