T2Dx®

Basic Information

• Brand Name: T2Dx®
• Primary DI: M70870049330
• Version / Model: 70-04933
• Company Name: T2 BIOSYSTEMS, INC.
• Labeler DUNS: 803126320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: d79278b6-8e36-4a3f-b952-afe946d12144

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60528	Magnetic particle separation instrument IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the automated pre-analytical extraction of specific molecules from a clinical specimen using magnetic particle separation techniques. It is a software-controlled, liquid handling robotic instrument that processes solutions using sequential immersion of magnetized rods, to attract labelled molecules, and rotation of demagnetized rods to create a new suspension/solution, and is typically used for nucleic acid isolation procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M70870049330	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN140019	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius