T-Cell Select®

FDA UDI

Class III (US FDA UDI)

by Oxford Immunotec, Inc.

Identity

Trade Name: T-Cell Select® FDA UDI
Generic Name: T lymphocyte magnetic separation reagent IVD FDA UDI
Device Name: The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture. FDA UDI
Model / Reference: TSK.910 FDA UDI
Description: The T-SPOT.TB test has been evaluated for the processing of blood samples within 8 hours of venipuncture. With the T-Cell Select reagent kit, blood samples stored or maintained at room temperature (18 – 25 °C) for up to 54 (0 – 54) hours post venipuncture can be used with the T-SPOT.TB test. The T-Cell Select reagent may also enable automation of the cell isolation process and reduce sample separation time relative to preparation via the density gradient separation methodology. With the T-Cell Select reagent kit, blood samples may be shipped and/or stored overnight at room temperature (18 – 25 °C), up to 54 (0 – 54) hours post venipuncture. FDA UDI

Identifiers

Catalog Number: TSK.910US FDA UDI
Primary DI / UDI-DI: 05051716000186 FDA UDI
PMA Number: P070006 FDA UDI
FDA Product Code: OJN FDA UDI
GMDN Term: T lymphocyte magnetic separation reagent IVD FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: T lymphocyte magnetic separation reagent IVD

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

Cleared under the same submission

P070006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Oxford Immunotec, Inc.

Sources (1)

FDA UDI fecc2d1c-c4bc-4942-af2e-da8de5ae5be7 35 fields · synced Jun 1, 2026