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T-Spot®.tb8

FDA UDI

Class III (US FDA UDI)

by Oxford Immunotec, Inc.

Identity

Trade Name
T-SPOT®.TB8 FDA UDI
Generic Name
Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations. FDA UDI
Model / Reference
TB.300 FDA UDI
Description
For the detection of effector t cells that respond to stimulation by mycobacterium tuberculosis antigens esat-6 and cfp-10 and indicated for use as an aid in the diagnosis of m.Tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations. FDA UDI

Identifiers

Catalog Number
TB.300US FDA UDI
Primary DI / UDI-DI
15051716000305 FDA UDI
PMA Number
P070006 FDA UDI
FDA Product Code
OJN FDA UDI
GMDN Term
Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA) 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: Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA)

T-Spot®.tb8 by Oxford Immunotec, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mycobacterium tuberculosis complex species antigen IVD, kit, enzyme immunoassay (EIA).

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 19e99fa4-a37a-4a9b-afa6-72d912e3d30b 36 fields · synced May 30, 2026