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 Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD Magnetic cell separation reagent IVD 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.