FDA.reportPublic FDA data

EasySep™ Human Bone Marrow CD138 Positive Selection Kit

Primary DI
17540207107480
Brand
EasySep™ Human Bone Marrow CD138 Positive Selection Kit
Company
Stemcell Technologies Canada Inc
Model
100-0748
Catalog number
100-0748
Device description
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.
Published
2024-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYOHematopoietic Cell Enrichment Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYOHematopoietic Cell Enrichment Kit Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220090000EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)Stemcell Technologies Canada, Inc.2023-11-06QYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540207107483PrimaryGS10
17540207107480Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540207107483075402071074837540207107483
1754020710748017540207107480

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic cell separation reagent IVDAn in vitro diagnostic substance or reactant intended to selectively bind one or more specific epitopes expressed by cells in heterogeneous human cell preparations for the subsequent magnetic separation of a target cell population. It typically consists of antibodies coupled to magnetic beads/spheres, whereby bound cells are separated from the initial cell preparation through the application of a magnet. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.667.0322techsupport@stemcell.com

Regulatory Flags#

DUNS number
252152400
Device count
3
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540207107483EasySep™ 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
07540207854509SepMate-5085450854502022-10-21
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
07540207107483EasySep™ Human Bone Marrow CD138 Positive Selection KitStemcell Technologies Canada IncQYO2024-02-08