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T2Dx®

FDA UDI

Class II (US FDA UDI)

by T2biosystems, Inc.

Identity

Trade Name
T2Dx® FDA UDI
Generic Name
Magnetic particle separation instrument IVD FDA UDI
Device Name
Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing. FDA UDI
Model / Reference
70-04933 FDA UDI
Description
Instrument is a multiplex instrument that uses molecular amplification and magnetic resonance detection in a single bench top housing. FDA UDI

Identifiers

Primary DI / UDI-DI
M70870049330 FDA UDI
510(k) Number
DEN140019 FDA UDI
FDA Product Code
NSU FDA UDI
GMDN Term
Magnetic particle separation instrument IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Magnetic particle separation instrument IVD

T2Dx® by T2biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic particle separation instrument IVD.

Cleared under the same submission

DEN140019 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
T2biosystems, Inc.

Sources (1)

  • FDA UDI d79278b6-8e36-4a3f-b952-afe946d12144 36 fields · synced May 30, 2026