T-Cell Select®

Primary DI
05051716000131
Brand
T-Cell Select®
Company
Oxford Immunotec, Inc.
Model
TSK.960
Catalog number
TSK.960
Device 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.
Published
2026-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJNMycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot TestUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P070006015

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070006015T SPOT-TB TESTOxford Immunotec, Ltd.2008-07-30OJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051716000131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051716000131050517160001315051716000131

GMDN Terms#

Term, Definition table
TermDefinition
T lymphocyte magnetic separation reagent IVDA substance or reactant intended to be used on clinical specimens for the isolation of T-lymphocytes from a white cell preparation using magnetic beads to achieve component separation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009744265
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051716000544Leucosep TubesLTK.615 USLTK.615 US2023-03-31
05051716000087Leucosep TubesLTK.615LTK.6152023-02-07
05051716000155AIM-V MediumAV.200/500AV.200/5002023-02-07
05051716000162AIM-V MediumAV.200/50AV.200/502023-02-07
05051716000186T-Cell Select®TSK.910TSK.910US2023-02-07
15051716000008T-SPOT®.TB96TB.200TB.200US2015-09-15
15051716000022T.Cell Xtend®TTK.610TTK.610US2014-08-12
15051716000046T-SPOT®.TB50TB.50TB.50US2014-08-12
15051716000053T.Cell Xtend®TTK.650TTK.650US2014-08-12
15051716000305T-SPOT®.TB8TB.300TB.300US2014-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051716000186T-Cell Select®Oxford Immunotec, Inc.OJN2023-02-07
15051716000008T-SPOT®.TB96Oxford Immunotec, Inc.OJN2015-09-15
15051716000022T.Cell Xtend®Oxford Immunotec, Inc.OJN2014-08-12
15051716000046T-SPOT®.TB50Oxford Immunotec, Inc.OJN2014-08-12
15051716000053T.Cell Xtend®Oxford Immunotec, Inc.OJN2014-08-12
15051716000305T-SPOT®.TB8Oxford Immunotec, Inc.OJN2014-08-12