FILMARRAY® COMMERCIAL LAPTOP COMP-SUB-0034

GUDID 00851458005297

FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument

BIOFIRE DEFENSE, LLC

Thermal cycler nucleic acid amplification analyser IVD, laboratory

• Primary Device ID: 00851458005297
• NIH Device Record Key: 650ab660-e323-45e2-8c3e-9f2e41602208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FILMARRAY® COMMERCIAL LAPTOP
• Version Model Number: COMP-SUB-0034
• Catalog Number: COMP-SUB-0034
• 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: 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
• 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
• Phone: 801-262-3592
• Email: support@biofiredefense.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143178

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: 2024-03-27
• Device Publish Date: 2024-03-19

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• 00851458005297 - FILMARRAY® COMMERCIAL LAPTOP: 2024-03-27FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
• 00851458005297 - FILMARRAY® COMMERCIAL LAPTOP: 2024-03-27 FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
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• 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