Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Biofire Defense, LLC. It received FDA 510(k) clearance on 2022-10-20 under approval 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. It is manufactured by Biofire Defense, LLC. The 510(k) number is K220870.

When was BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel approved by the FDA?

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

What company makes 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 manufactured by Biofire Defense, LLC.

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

NCT07614113 Atropine Alone vs Atropine Plus Bifocal Spectacles for Myopia Control in Children COMPLETED NCT07343141 To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds NOT_YET_RECRUITING NCT06915012 Impact of Biophoton Therapy on Chronic Severe Arthritis Pain RECRUITING NCT06556537 Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas. ACTIVE_NOT_RECRUITING NCT07592377 Multicenter Study on the Use of a Collagen-based Hydrogel for the Treatment of 153 Periodontal Pockets in 38 Adults With Generalized Stage III Periodontitis COMPLETED NCT06724510 Safety and Efficacy Evaluation of High Intensity Focused Ultrasound Device in Eyebrow Lifting COMPLETED

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 K221460BioFire COVID-19 Test 2

View all 9 devices →

Related Devices (Code: QMV)

DEN200043FilmArray Global Fever PanelBiofire Defense, LLC 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.

↑