← Back to catalogue

T2Candida® Reagent Trays

FDA UDI

Class II (US FDA UDI)

by T2biosystems, Inc.

Identity

Trade Name
T2Candida® Reagent Trays FDA UDI
Generic Name
Multiple Candida species nucleic acid IVD, reagent FDA UDI
Device Name
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel. FDA UDI
Model / Reference
80-01689 FDA UDI
Description
The T2Candida component that contains the refrigerated reagents used to perform the T2Candida panel. FDA UDI

Identifiers

Primary DI / UDI-DI
M70880016893 FDA UDI
510(k) Number
DEN140019 FDA UDI
FDA Product Code
PII FDA UDI
GMDN Term
Multiple Candida species 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 Candida species nucleic acid IVD, reagent

T2Candida® Reagent Trays by T2biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple Candida species nucleic acid IVD, reagent.

Cleared under the same submission

DEN140019 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
T2biosystems, Inc.

Sources (1)

  • FDA UDI d3bc7271-de7f-4233-bbd2-29de4ae036a3 36 fields · synced May 30, 2026