FILMARRAY NGDS WARRIOR PANEL - CA DFA2-ASY-0012

GUDID 00851458005266

FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)

BIOFIRE DEFENSE, LLC

Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00851458005266
• NIH Device Record Key: c6b8fab5-db5e-429e-bbc2-fdd5c86462d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FILMARRAY NGDS WARRIOR PANEL - CA
• Version Model Number: DFA2-ASY-0012
• Catalog Number: DFA2-ASY-0012
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005266 [Primary]

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: 2024-06-28
• Device Publish Date: 2024-06-20

Devices Manufactured by BIOFIRE DEFENSE, LLC

• 00851458005266 - FILMARRAY NGDS WARRIOR PANEL - CA: 2024-06-28FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
• 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
• 00851458005228 - BioFire® COVID-19 Test 2: 2023-02-24 BioFire® COVID-19 Test 2 - IVD reagent kit containing 6 tests
• 00851458005235 - BioFire® COVID-19 Test 2: 2023-02-24 BioFire® COVID-19 Test 2 - IVD reagent kit containing 30 tests
• 00851458005242 - BioFire® Global Fever Panel: 2021-07-26 BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
• 00851458005259 - BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel: 2021-07-26 BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit