Erytra

Basic Information

• Brand Name: Erytra
• Primary DI: 08437014205220
• Version / Model: 210400
• Catalog Number: 210400
• Company Name: DIAGNOSTIC GRIFOLS SA
• Labeler DUNS: 463625602
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-20
• Public Version: 3
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: dcba80b9-059e-4602-8eb0-b37b9cb6c955

Device Description

The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel® 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), the Erytra® automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSZ	System, Test, Automated Blood Grouping And Antibody	Hematology	864.9175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57846	Immunohaematology/blood bank analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to perform blood grouping, red cell phenotyping, antibody screening/identification/titration, direct antiglobulin tests and/or crossmatching of clinical specimens (from donor and patient). It utilizes one or more immunological methods which may include microplate agglutination, column agglutination technology or nephelometry, together with an enzymic, photometric or radiometric detection system, and sample processing, data processing and/or data display software.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08437014205220	GS1

Customer Contacts

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