Referencells

Basic Information

• Brand Name: Referencells
• Primary DI: 10888234001522
• Version / Model: 0066900
• Catalog Number: 0066900
• Company Name: IMMUCOR, INC.
• Labeler DUNS: 061446282
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-03
• Public Version: 1
• Public Version Date: 2022-08-11
• Public Version Status: New
• Public Device Record Key: 89c77978-a4d7-40e0-9340-2b6190002a69

Device Description

Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

Device Characteristics

• Single Use: Yes
• 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: 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QHT	Reagent Red Blood Cells	Hematology	660.30	U

GMDN Terms

Code	Name	Definition	Implantable	Status
58814	Solid-phase red blood cell adherence antibody/antigen IVD	A microplate or test strip of protein-activated wells intended to be used in immunohaematological testing of a clinical specimen for the detection and/or identification of red blood cell antibodies or antigens, using a solid-phase red blood cell adherence method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234001522	GS1