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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
Classification Name: MULTIPLEX NUCLEIC ACID DETECTION SYSTEM FOR BIOTHREAT AGENTS
Product Code: QVR
Device Class: 2
Regulation Number: 866.4000
Medical Specialty: Immunology
Registered Establishment Name: BioFire Defense, LLC
Registered Establishment Number: 3010770794
Premarket Submission Number: K213362
Owner/Operator: BIOMERIEUX SA
Owner/Operator Number: 8020790
Establishment Operations: Manufacturer
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