FDA 510(k)

BioFire COVID-19 Test 2

Número K: K221460 · 2022-07-25

Data da decisão2022-07-25

Código do produtoQQX

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

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 2022-07-25 under 510(k) number K221460. The device is classified under product code QQX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioFire COVID-19 Test 2?

BioFire COVID-19 Test 2 is a medical device that received FDA 510(k) clearance on 2022-07-25. The listed applicant is Biofire Defense, LLC. The 510(k) number is K221460.

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

BioFire COVID-19 Test 2 received FDA 510(k) clearance on 2022-07-25, under 510(k) number K221460.

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.

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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 K213362BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel K220870BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel K211079BioFire COVID-19 Test 2 K202382FilmArray Global Fever Panel External Control Kit

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: QQX)

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 Molecular K233453Kit de Diagnóstico PCR COVID-19 TaqPath™ da Applied Biosystems™Life Technologies Corporation K230440Xpert® Xpress CoV-2 plusCepheid®

Fonte oficial

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