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Found 3 results

510(k) Data Aggregation

K Number

Device Name

BioFire Warrior Panel; BioFire Warrior Panel Control Kit

Manufacturer

BioFire Defense, LLC

Date Cleared

2025-03-12

(90 days)

Product Code

PRD

Regulation Number

N/A

Why did this record match?

Product Code :

PRD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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K Number

Device Name

FilmArray NGDS Warrior Panel

Manufacturer

BioFire Defense, LLC

Date Cleared

2017-06-22

(90 days)

Product Code

PRD

Regulation Number

N/A

Why did this record match?

Product Code :

PRD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

K Number

Device Name

FilmArray NGDS Warrior Panel

Manufacturer

BioFire Defense, LLC

Date Cleared

2017-02-14

(120 days)

Product Code

PRD

Regulation Number

N/A

Why did this record match?

Product Code :

PRD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

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