EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate

Basic Information

• Brand Name: EasySep™ Red Blood Cell Lysis Buffer, 10X Concentrate
• Primary DI: 07540207107490
• Version / Model: 100-0749
• Catalog Number: 100-0749
• Company Name: Stemcell Technologies Canada Inc
• Labeler DUNS: 252152400
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-08
• Public Version: 1
• Public Version Date: 2024-02-16
• Public Version Status: New
• Public Device Record Key: c1524ed9-3f13-49ca-98d1-e633cbbedf87

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GGK	Products, Red-Cell Lysing Products	Hematology	864.8540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61165	Blood cell lysis reagent IVD	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540207107490	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius