EasySep™ Human Bone Marrow CD138 Positive Selection Kit 100-0748

GUDID 17540207107480

EasySep Human Bone Marrow CD138 Positive Selection Kit is designed to enrich plasma cells expressing the CD138 (syndecan-1) surface antigen from fresh whole bone marrow aspirates.

Stemcell Technologies Canada Inc

Magnetic cell separation reagent IVD

• Primary Device ID: 17540207107480
• NIH Device Record Key: a7b7ebf7-8d89-4430-b66a-9a7162317e7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasySep™ Human Bone Marrow CD138 Positive Selection Kit
• Version Model Number: 100-0748
• Catalog Number: 100-0748
• Company DUNS: 252152400
• Company Name: Stemcell Technologies Canada Inc
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com
• Phone: 1.800.667.0322
• Email: techsupport@stemcell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540207107483 [Primary]
GS1	17540207107480 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220090

FDA Product Code

• QYO: Hematopoietic Cell Enrichment Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

Devices Manufactured by Stemcell Technologies Canada Inc

• 17540207107480 - EasySep™ Human Bone Marrow CD138 Positive Selection Kit: 2024-02-16EasySep Human Bone Marrow CD138 Positive Selection Kit is designed to enrich plasma cells expressing the CD138 (syndecan-1) surface antigen from fresh whole bone marrow aspirates.
• 17540207107480 - EasySep™ Human Bone Marrow CD138 Positive Selection Kit: 2024-02-16 EasySep Human Bone Marrow CD138 Positive Selection Kit is designed to enrich plasma cells expressing the CD138 (syndecan-1) surf
• 07540207107490 - EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate: 2024-02-16 EasySep™ RBC Lysis Buffer contains NH4Cl which allows osmotic lysis of red blood cells to obtain the targeted cells. It has s
• 07540207107803 - EasySep™ Buffer: 2024-02-16 EasySep™ Buffer is a cell separation buffer required for use with EasySep™ IVD Cell Isolation Kit. It contains Dulbecco’s
• 17540207854155 - SepMate-15: 2023-09-22 SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes) from human whole blood or bone
• 17540207854506 - SepMate-50: 2023-09-22 SepMate is a tube used to isolate mononuclear cells (MNCs, comprising lymphocytes and monocytes) from human whole blood or bone
• 07540207854165 - SepMate-15: 2022-10-31 SepMate is a tube that facilitates the isolation of PBMCs or specific cell types by density gradient centrifugation.
• 07540207854516 - SepMate-50: 2022-10-31 SepMate is a tube that facilitates the isolation of PBMCs or specific cell types by density gradient centrifugation.