Referencells A2

Basic Information

• Brand Name: Referencells A2
• Primary DI: 10888234000266
• Version / Model: 0002342
• Catalog Number: 0002342
• 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: d155fd7b-c5d1-4a9c-b8b0-9151a5d82920

Device Description

This configuration of the product contains one (1) vial, namely known A2 red blood cells, and is used for the confirmation of reverse expected ABO serum grouping antibodies.

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
52525	Group A2 Rh (D) 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 blood group A2 Rh(D) positive. These reagent cells are positive for blood group antigen A [ABO001] and Rh(D) [RH001] but negative for blood group antigen A1 [ABO004].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234000266	GS1

Customer Contacts

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

Storage Conditions

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