T2Bacteria® Reagent Trays

GUDID M70880080720

The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.

T2 BIOSYSTEMS, INC.

Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent Multiple-type bloodstream pathogen nucleic acid IVD, reagent

• Primary Device ID: M70880080720
• NIH Device Record Key: 6a101fa6-247d-4a85-ba48-8c7c8a9bef65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2Bacteria® Reagent Trays
• Version Model Number: 80-08072
• Company DUNS: 803126320
• Company Name: T2 BIOSYSTEMS, INC.
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com
• Phone: 877-504-8282
• Email: t2service@t2biosystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M70880080720 [Unit of Use]
HIBCC	M70880080723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172708

FDA Product Code

• QBX: Direct Blood Bacterial 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: 2024-02-28
• Device Publish Date: 2024-02-20

On-Brand Devices [T2Bacteria® Reagent Trays]

• M70880073423: The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria
• M70880080720: The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria