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T2Biothreat® Cartridge Kit

FDA UDI

Class II (US FDA UDI)

by T2biosystems, Inc.

Identity

Trade Name
T2Biothreat® Cartridge Kit FDA UDI
Generic Name
Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent FDA UDI
Model / Reference
90-11400 FDA UDI
Description
The T2Biothreat Panel components used to load the patient sample to be run and that contains disposables and Lysis Reagent FDA UDI

Identifiers

Primary DI / UDI-DI
M70890114000 FDA UDI
510(k) Number
K231336 FDA UDI
FDA Product Code
QVR FDA UDI
QBX FDA UDI
NSU FDA UDI
GMDN Term
Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.4000 FDA UDI
866.3960 FDA UDI
862.2570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

T2Biothreat® Cartridge Kit by T2biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

K231336 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 a23b2609-2354-43b7-be4e-2d75cb72c886 36 fields · synced Jun 1, 2026