JBAIDS JRPD-ASY-0124

GUDID 00851458005020

JBAIDS IVD Tularemia Detection Kit

BIOFIRE DEFENSE, LLC

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• Primary Device ID: 00851458005020
• NIH Device Record Key: 8c46806e-c282-4514-800b-535889ccffbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JBAIDS
• Version Model Number: JRPD-ASY-0124
• Catalog Number: JRPD-ASY-0124
• 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
• 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	00851458005020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131936

FDA Product Code

• OEH: Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

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• 00851458005075: JBAIDS IVD Influenza A Subtyping Kit
• 00851458005068: JBAIDS IVD Influenza A & B Detection Kit
• 00851458005044: JBAIDS IVD Plague Detection Kit
• 00851458005037: JBAIDS IVD Anthrax Detection Kit
• 00851458005020: JBAIDS IVD Tularemia Detection Kit
• 00851458005013: JBAIDS IVD Q Fever Detection Kit
• 00851458005006: JBAIDS Instrument