SPOTFIRE Control Station - non-ITAR FAST-ASY-0001-B

GUDID 00851458005334

BIOFIRE SPOTFIRE Control Station IVD non-ITAR Configuration

BIOFIRE DEFENSE, LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 00851458005334
• NIH Device Record Key: 137fc2a0-c1b8-48cb-881a-0378cd86eb01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPOTFIRE Control Station - non-ITAR
• Version Model Number: FAST-ASY-0001-B
• Catalog Number: FAST-ASY-0001-B
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213954

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by BIOFIRE DEFENSE, LLC

• 00851458005327 - SPOTFIRE Control Station - ITAR: 2025-12-24 BIOFIRE SPOTFIRE Control Station IVD ITAR Configuration
• 00851458005334 - SPOTFIRE Control Station - non-ITAR: 2025-12-24BIOFIRE SPOTFIRE Control Station IVD non-ITAR Configuration
• 00851458005334 - SPOTFIRE Control Station - non-ITAR: 2025-12-24 BIOFIRE SPOTFIRE Control Station IVD non-ITAR Configuration
• 00851458005303 - BioFire Warrior Panel: 2025-08-18 NGDS IVD Reagent Biothreat Detection Kit containing 30 tests.
• 00851458005310 - BioFire Warrior Panel Control Kit: 2025-08-18 IVD Reagent External Control Kit for the BioFire Warrior Panel
• 00851458005266 - FILMARRAY NGDS WARRIOR PANEL - CA: 2024-06-28 FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
• 00851458005297 - FILMARRAY® COMMERCIAL LAPTOP: 2024-03-27 FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
• 00851458005273 - BioFire® Global Fever Special Pathogens Panel: 2023-09-08 BioFire® Global Fever Special Pathogens Panel - IVD reagent kit containing 6 tests
• 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