Hemantigen (Pooled Cells)

Basic Information

• Brand Name: Hemantigen (Pooled Cells)
• Primary DI: 10888234000174
• Version / Model: 0002223
• Catalog Number: 0002223
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a2fbf456-e1ab-4400-b84d-e59eecd6447b

Device Description

Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
52690	Pooled antibody screening reagent red blood cell IVD, antigen	A collection of two or three specifically characterized reagent red blood cells pooled together into a single sample, and intended to be used in screening a clinical specimen to detect antibodies to red blood cell antigens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000174	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 10 Degrees Celsius