Erytra 210400

GUDID 08437014205220

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.

DIAGNOSTIC GRIFOLS SA

Immunohaematology/blood bank analyser IVD, automated

• Primary Device ID: 08437014205220
• NIH Device Record Key: dcba80b9-059e-4602-8eb0-b37b9cb6c955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erytra
• Version Model Number: 210400
• Catalog Number: 210400
• Company DUNS: 463625602
• Company Name: DIAGNOSTIC GRIFOLS SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com
• Phone: (800) 452-6877
• Email: service.americas@grifols.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08437014205220 [Primary]

FDA Product Code

• KSZ: System, Test, Automated Blood Grouping And Antibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [Erytra]

• 08437014205220: The Erytra® is a fully-automated high-throughput analyzer designed to automate in vitro immunoh
• 08437014205190: The Erytra is a fully-automated high-throughput analyzer designed to automate in vitro immunohem