FDA 510(k)

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

Número K: K213362 · 2023-03-22

Data da decisão2023-03-22

Código do produtoQVR

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Biofire Defense, LLC. The 510(k) number is K213362.

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

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 510(k) number K213362.

Who is the listed applicant for BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens 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 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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Outros registros que listam Biofire Defense, LLC como candidato(a)

K261475BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit K243822BioFire Warrior Panel; BioFire Warrior Panel Control Kit K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel K221460BioFire COVID-19 Test 2 K211079BioFire COVID-19 Test 2 K202382FilmArray Global Fever Panel External Control Kit

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