Panocell-20

Basic Information

• Brand Name: Panocell-20
• Primary DI: 10888234001843
• Version / Model: 0005020
• Catalog Number: 0005020
• 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: dc9b22c1-0ded-4f3e-acdc-f40f7dae2f89

Device Description

This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as twenty (20) vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
52543	Antibody identification panel reagent red blood cell IVD, kit, agglutination	A collection of four or more specifically characterized reagent red blood cells that are supplied together as a set and intended to be used to determine the exact specificity of antibodies to red blood cell antigens present in a clinical specimen, using an agglutination method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888234001843	GS1

Customer Contacts

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

Storage Conditions

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