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T2Candida® External Controls

FDA UDI

Class II (US FDA UDI)

by T2biosystems, Inc.

Identity

Trade Name
T2Candida® External Controls FDA UDI
Generic Name
Multiple Candida species nucleic acid IVD, control FDA UDI
Device Name
IVD Positive APG, Positive TPK, Negative EDTA Kit FDA UDI
Model / Reference
85-04919 FDA UDI
Description
IVD Positive APG, Positive TPK, Negative EDTA Kit FDA UDI

Identifiers

Primary DI / UDI-DI
M70885049190 FDA UDI
510(k) Number
DEN140019 FDA UDI
FDA Product Code
PII FDA UDI
GMDN Term
Multiple Candida species nucleic acid IVD, control 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

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

Dimensions & Sizes

Size
Total Volume — 4 Milliliter FDA UDI

Category: Multiple Candida species nucleic acid IVD, control

T2Candida® External Controls 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, control.

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 1d7ede18-1c79-4eae-b85b-d13e30dcc41c 37 fields · synced May 30, 2026