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FDA 510(k)

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

K-Number: K213362 · 2023-03-22

ApplicantBiofire Defense, LLC
Decision Date2023-03-22
Product CodeQVR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is a medical device manufactured by Biofire Defense, LLC. It received FDA 510(k) clearance on 2023-03-22 under approval number K213362. The device is classified under product code QVR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Biofire Defense, LLC. The 510(k) number is K213362.

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

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel received FDA 510(k) clearance on 2023-03-22, under approval number K213362.

What company makes BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is manufactured by Biofire Defense, LLC.

What is the FDA product code for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel?

The FDA product code for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel is QVR.

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Related PubMed Literature

PMID: 42180407 Global pharmacovigilance reporting: comparative analysis of adverse event obligations across five major regulatory authorities. Frontiers in drug safety and regulation (2026)

Other Devices by Biofire Defense, LLC

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Related Devices (Code: QVR)

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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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