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T2Bacteria® Reagent Trays

FDA UDI

Class II (US FDA UDI)

by T2biosystems, Inc.

Identity

Trade Name
T2Bacteria® Reagent Trays FDA UDI
Generic Name
Multiple-type bloodstream pathogen nucleic acid IVD, reagent FDA UDI
Device Name
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel. FDA UDI
Model / Reference
80-07342 FDA UDI
Description
The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria panel. FDA UDI

Identifiers

Primary DI / UDI-DI
M70880073423 FDA UDI
510(k) Number
K172708 FDA UDI
FDA Product Code
QBX FDA UDI
GMDN Term
Multiple-type bloodstream pathogen nucleic acid IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3960 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

No

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 bloodstream pathogen nucleic acid IVD, reagent

T2Bacteria® Reagent Trays by T2biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, reagent.

Cleared under the same submission

K172708 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 a59eef09-ff28-4062-a79c-3e5304ecbc60 36 fields · synced May 30, 2026