SepMate-50 85450

GUDID 17540207854506

SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes) from human whole blood or bone marrow by density centrifugation.

Stemcell Technologies Canada Inc

Centrifuge tube IVD
Primary Device ID17540207854506
NIH Device Record Keya389c824-b958-4713-98f5-715bb760a19a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSepMate-50
Version Model Number85450
Catalog Number85450
Company DUNS252152400
Company NameStemcell Technologies Canada Inc
Device Count100
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com
Phone1.800.667.0322
Emailtechsupport@stemcell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540207854509 [Primary]
GS117540207854506 [Unit of Use]

FDA Product Code

JCFLymphocyte Separation Medium

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-22
Device Publish Date2022-10-21

On-Brand Devices [SepMate-50]

07540207854516SepMate is a tube that facilitates the isolation of PBMCs or specific cell types by density grad
17540207854506SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes)

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