BioFire Warrior Panel NGDS-ASY-0018

GUDID 00851458005303

NGDS IVD Reagent Biothreat Detection Kit containing 30 tests.

BIOFIRE DEFENSE, LLC

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

• Primary Device ID: 00851458005303
• NIH Device Record Key: 2be8c6cd-67f4-4e16-812d-f5ea7311697b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioFire Warrior Panel
• Version Model Number: NGDS-ASY-0018
• Catalog Number: NGDS-ASY-0018
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243822

FDA Product Code

• PRD: Biothreat Microbial Agents Multiplex Nucleic Acid Detection System

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: 2025-08-18
• Device Publish Date: 2025-08-10

Devices Manufactured by BIOFIRE DEFENSE, LLC

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• 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