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T.Cell Xtend®

FDA UDI

Class III (US FDA UDI)

by Oxford Immunotec, Inc.

Identity

Trade Name
T.Cell Xtend® FDA UDI
Generic Name
Cell centrifugation/density gradient separation reagent IVD FDA UDI
Device Name
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c). FDA UDI
Model / Reference
TTK.650 FDA UDI
Description
Approval for the use of t-cell xtend reagent with the t-spot. Tb test, in order to extend the time from sample collection to sample processing from within 8 hours of venipuncture to between 23 and 30 hours post venipuncture; and to make a technical correction to the t-spot. Tb test package insert to change the number of blood collection tubes required from (2) 6 ml heparin tubes to (1) 6 ml heparin tube. The t-cell xtend reagent is indicated for use with the t-spot. Tb test for the pre-treatment of whole blood prior to lymphocyte separation. The reagent aids in the removal of selected white blood cells from whole blood stored at room temperature (18-25 degrees c). FDA UDI

Identifiers

Catalog Number
TTK.650US FDA UDI
Primary DI / UDI-DI
15051716000053 FDA UDI
PMA Number
P070006 FDA UDI
FDA Product Code
OJN FDA UDI
GMDN Term
Cell centrifugation/density gradient separation reagent IVD FDA UDI

Classification

Device Class
Class III 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

No

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: Cell centrifugation/density gradient separation reagent IVD

T.Cell Xtend® by Oxford Immunotec, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cell centrifugation/density gradient separation reagent IVD.

Cleared under the same submission

P070006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oxford Immunotec, Inc.

Sources (1)

  • FDA UDI 11ffccf0-a1ca-4484-a968-9821054ec70b 36 fields · synced May 30, 2026