Di(a+) Cell

Basic Information

• Brand Name: Di(a+) Cell
• Primary DI: 10888234000471
• Version / Model: 0005021
• Catalog Number: 0005021
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-30
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c8967086-a8d0-4cbd-b0dc-822eb53e984a

Device Description

Di(a+) Cell is used in the detection of unexpected red blood cell blood group antibodies. Di(a+) Cell is a single vial of group O, Di(a+) red blood cells.

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
61232	Di^a positive reagent red blood cell IVD, antigen	A sample of specifically characterized reagent red blood cells intended to be used in testing a clinical specimen due to their classification as Di^a positive. These reagent cells are positive for the Diego blood group antigen Di^a [DI001].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000471	GS1

Customer Contacts

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

Storage Conditions

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