FDA.reportPublic FDA data

EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate

Primary DI
07540207107490
Brand
EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate
Company
Stemcell Technologies Canada Inc
Model
100-0749
Catalog number
100-0749
Device description
EasySep™ RBC Lysis Buffer contains NH4Cl which allows osmotic lysis of red blood cells to obtain the targeted cells. It has suitable, physiologically relevant pH optimized to maintain cell survival. It also has osmolality similar to the natural environment of the cells to maintain balanced osmotic pressure.
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
GGKProducts, Red-Cell Lysing Products

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGKProducts, Red-Cell Lysing ProductsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540207107490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540207107490075402071074907540207107490

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell lysis reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 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
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

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Primary DI, Brand, Company table
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00630414312491Atellica HEMA DiffSiemens Healthcare Diagnostics Inc.GGK2026-02-06
06903053010641M-30CFL LYSEShenzhen Mindray Bio-Medical Electronics Co., Ltd.GGK2026-01-22
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