FDA.reportPublic FDA data

Leucosep Tubes

Primary DI
05051716000087
Brand
Leucosep Tubes
Company
Oxford Immunotec, Inc.
Model
LTK.615
Catalog number
LTK.615
Device description
Leucosep® tubes are intended for use in the collection and separation of peripheral blood mononuclear cells (PBMCs) from whole blood. The tubes facilitate the separation of PBMCs from whole blood when using a polysucrose-based gradient separation solution procedure prior to the use of these cells in ELISPOT assays. ELISPOT techniques utilize T cells in PBMCs that have been separated from whole blood. One method for separating these cells requires the use of a poly-sucrose-based gradient separation solution. This procedure involves a number of steps which should be carried out with care to ensure optimal results. The use of Leucosep tubes reduces the number of steps and reduces the amount of time required to perform the separation procedure.
Published
2023-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JCFLymphocyte Separation Medium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCFLymphocyte Separation MediumHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051716000087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051716000087050517160000875051716000087

GMDN Terms#

Term, Definition table
TermDefinition
Cell centrifugation/density gradient separation reagent IVDA substance or reactant intended to be used for the isolation of cells from a clinical specimen (e.g., lymphocytes from whole blood, cells from a liquid-based cytology specimen) using centrifugation and density gradient to achieve specimen component separation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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
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
05407010126969TheraPEAK® T-VIVO® MEDIUM 5L BAGLonza VerviersJCF2025-05-14
05407010125818X-VIVO 10 with Gent and Phenol Red, 1LLonza VerviersJCF2025-02-10
00628451099017Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099024Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099048Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099482Lympholyte-HCedarlane CorporationJCF2024-12-10
00628451099499Lympholyte-HCedarlane CorporationJCF2024-12-10
05051716000544Leucosep TubesOxford Immunotec, Inc.JCF2023-03-31
05407010124279X-Vivo10 w/o Gent, PR w/ Rec Transf, 1LLonza VerviersJCF2022-12-09
05407010124330X-VIVO 15 w/o PR and Gentamicine 1L bagLonza VerviersJCF2022-12-09
05407010124347X-VIVO 15 w/o PR and Gentamicine 1L bag sampleLonza VerviersJCF2022-12-09
06284510990011Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990028Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990042Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990486Lympholyte-HCedarlane CorporationJCF2022-12-08
06284510990493Lympholyte-HCedarlane CorporationJCF2022-12-08
07540207854158SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
07540207854509SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
17540207854155SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
17540207854506SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
07540207854165SepMate-15Stemcell Technologies Canada IncJCF2022-10-21
07540207854516SepMate-50Stemcell Technologies Canada IncJCF2022-10-21
05407010122565STD X-Vivo 15 w/o gentamicin and pr, 1LLonza VerviersJCF2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersJCF2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersJCF2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersJCF2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersJCF2022-09-12
05407010122824TheraPEAK X-VIVO10(04-743) contains rec transf -1LLonza VerviersJCF2022-09-12
05407010122831X-VIVO 10 w/o Gentamycin w/o PR, 1LLonza VerviersJCF2022-09-12
05407010122848TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza VerviersJCF2022-09-12