T2Dx®

GUDID M70870049330

Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.

T2 BIOSYSTEMS, INC.

Magnetic particle separation instrument IVD

• Primary Device ID: M70870049330
• NIH Device Record Key: d79278b6-8e36-4a3f-b952-afe946d12144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2Dx®
• Version Model Number: 70-04933
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M70870049330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN140019

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2017-02-12

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• M70880080720 - T2Bacteria® Reagent Trays: 2024-02-28 The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
• M70885080730 - T2Bacteria® QCheck Positive Kit: 2024-02-28 Positive ASK Control, Positive EPE Control
• M70885080743 - T2Bacteria® QCheck Negative Kit: 2024-02-16 Negative Control for T2Bacteria Panel
• 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®: 2022-09-16Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing.
• M70870049330 - T2Dx®: 2022-09-16 Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top ho