JBAIDS JRPD-ASY-0123

GUDID 00851458005044

JBAIDS IVD Plague Detection Kit

BIOFIRE DEFENSE, LLC

Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT) Yersinia pestis nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 00851458005044
• NIH Device Record Key: 4e334c04-9d56-4d09-9581-f5c5598b0404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JBAIDS
• Version Model Number: JRPD-ASY-0123
• Catalog Number: JRPD-ASY-0123
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851458005044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131729

FDA Product Code

• OIH: Yersinia Spp. Reagents

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

On-Brand Devices [JBAIDS]

• 00851458005082: JBAIDS IVD Influenza A/H5 Detection Kit
• 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