ELUclear

Basic Information

• Brand Name: ELUclear
• Primary DI: 00858352006023
• Version / Model: H360
• Catalog Number: H360
• Company Name: HEMO BIOSCIENCE INC
• Labeler DUNS: 143647035
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 727fc6a5-83fc-496c-8b4a-d9fe04537384

Device Description

ELUclear elution kit is used to elute antibodies from intact red blood cells.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSG	Media, Potentiating For In Vitro Diagnostic Use	Hematology	864.9600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52733	Red cell antibody eluting IVD, kit	A collection of reagents and other associated materials intended to be used for the elution of antibodies bound to antigens present on the surface of red blood cells in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858352006023	GS1

Customer Contacts

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