T2Bacteria® Cartridge Kit

GUDID M70890080710

The T2Bacteria Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Bacteria panel.

T2 BIOSYSTEMS, INC.

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: M70890080710
• NIH Device Record Key: 8e9e4106-a785-4878-b889-7acb7d25d7b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2Bacteria® Cartridge Kit
• Version Model Number: 90-08071
• Company DUNS: 803126320
• Company Name: T2 BIOSYSTEMS, INC.
• 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: 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 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M70890080710 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-12-21
• Device Publish Date: 2018-08-02

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• M70880113930 - T2Biothreat® Reagent Trays: 2023-11-15 The T2Biothreat Panel component that contains the assay reagent
• M70883113950 - T2Biothreat® QCheck Positive Kit: 2023-11-15 Buffer based solution with containing non-pathogenic bacterial strains with the T2Biothreat Panel target sequences.
• M70883113970 - T2Biothreat® QCheck Negative Kit: 2023-11-15 Negative quality control for T2Biothreat Panel
• M70870049330 - T2Dx®: 2022-09-16 Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top ho