FDA.reportPublic FDA data

SepMate-50

Primary DI
07540207854509
Brand
SepMate-50
Company
Stemcell Technologies Canada Inc
Model
85450
Catalog number
85450
Device description
SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes) from human whole blood or bone marrow by density centrifugation.
Published
2022-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
07540207854509PrimaryGS10
17540207854506Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540207854509075402078545097540207854509
1754020785450617540207854506

GMDN Terms#

Term, Definition table
TermDefinition
Centrifuge tube IVDA tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1.800.667.0322techsupport@stemcell.com

Regulatory Flags#

DUNS number
252152400
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540207107483EasySep™ Human Bone Marrow CD138 Positive Selection Kit100-0748100-07482024-02-08
17540207107480EasySep™ Human Bone Marrow CD138 Positive Selection Kit100-0748100-07482024-02-08
07540207107490EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate100-0749100-07492024-02-08
07540207107803EasySep™ Buffer100-0780100-07802024-02-08
07540207854158SepMate-1585415854152022-10-21
17540207854155SepMate-1585415854152022-10-21
17540207854506SepMate-5085450854502022-10-21
07540207854165SepMate-1585415854152022-10-21
07540207854516SepMate-5085450854502022-10-21

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
05051716000087Leucosep TubesOxford Immunotec, Inc.JCF2023-02-07
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
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