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 Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory Thermal cycler nucleic acid amplification analyser IVD, laboratory 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

Devices Manufactured by BIOFIRE DEFENSE, LLC

• 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
• 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
• 00851458005068 - JBAIDS: 2020-02-12 JBAIDS IVD Influenza A & B Detection Kit