T-Cell Select®

Primary DI
05051716000186
Brand
T-Cell Select®
Company
OXFORD IMMUNOTEC LIMITED
Model
TSK.910
Catalog number
TSK.910US
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
2023-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
05051716000186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051716000186050517160001865051716000186

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.

Regulatory Flags#

DUNS number
641127308
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051716000131T-Cell Select®TSK.960TSK.9602026-01-15
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
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
05051716000131T-Cell Select®OXFORD IMMUNOTEC LIMITEDOJN2026-01-15
15051716000008T-SPOT®.TB96OXFORD IMMUNOTEC LIMITEDOJN2015-09-15
15051716000022T.Cell Xtend®OXFORD IMMUNOTEC LIMITEDOJN2014-08-12
15051716000046T-SPOT®.TB50OXFORD IMMUNOTEC LIMITEDOJN2014-08-12
15051716000053T.Cell Xtend®OXFORD IMMUNOTEC LIMITEDOJN2014-08-12
15051716000305T-SPOT®.TB8OXFORD IMMUNOTEC LIMITEDOJN2014-08-12