BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane DFA2-ASY-0019

GUDID 00851458005280

BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit

BIOFIRE DEFENSE, LLC

Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, control

• Primary Device ID: 00851458005280
• NIH Device Record Key: 102fbd63-1162-478b-84a6-e21e010573c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane
• Version Model Number: DFA2-ASY-0019
• Catalog Number: DFA2-ASY-0019
• Company DUNS: 556915205
• Company Name: BIOFIRE DEFENSE, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com
• Phone: 801-262-3592
• Email: support@biofiredefense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213362

FDA Product Code

• QVR: Multiplex Nucleic Acid Detection System For Biothreat Agents

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

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• 00851458005280 - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane: 2023-09-08BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit
• 00851458005280 - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Pane: 2023-09-08 BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Special Pathogens Panel - IVD Reagent External Control Kit
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