FDA.reportPublic FDA data

EasySep™ Buffer

Primary DI
07540207107803
Brand
EasySep™ Buffer
Company
Stemcell Technologies Canada Inc
Model
100-0780
Catalog number
100-0780
Device description
EasySep™ Buffer is a cell separation buffer required for use with EasySep™ IVD Cell Isolation Kit. It contains Dulbecco’s phosphate-buffered saline (PBS) with 2% fetal bovine serum (FBS) and 1 mM EDTA.
Published
2024-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JCCPh Buffer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCCPh BufferPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540207107803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540207107803075402071078037540207107803

GMDN Terms#

Term, Definition table
TermDefinition
Buffered isotonic saline reagent IVDA buffered isotonic saline solution intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.

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
1
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
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
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