Erytra Eflexis 210600

GUDID 08437014205305

Erytra Eflexis® is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards techno

DIAGNOSTIC GRIFOLS SA

Immunohaematology/blood bank analyser IVD, automated

• Primary Device ID: 08437014205305
• NIH Device Record Key: 061c40f2-055e-477c-8975-1d6e320c9380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erytra Eflexis
• Version Model Number: 210600
• Catalog Number: 210600
• 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	08437014205305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK180260

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: 2019-03-29
• Device Publish Date: 2019-03-21

Devices Manufactured by DIAGNOSTIC GRIFOLS SA

• 08437014205008 - DG Gel 8 Neutral: 2025-04-22 The DG Gel 8 Neutral card is for the detection of antibodies to red blood cell antigens of human blood samples and for its use a
• 08437014205084 - DG Gel 8 Anti-K: 2025-04-16 The DG Gel 8 Anti-K card is for the determination of K antigen on the surface of red blood cells in eight human blood samples. F
• 08437014205091 - DG Gel 8 Anti-D: 2025-04-16 The DG Gel 8 Anti-D card is for the determination of D antigen on the surface of red blood cells of eight human blood samples. F
• 08437014205107 - DG Gel 8 Anti-AB: 2025-04-16 The DG Gel 8 Anti-AB card is for the determination of human A and B antigens on the surface of red blood cells of eight human bl
• 08437014205121 - DG Gel 8 Anti-E: 2025-04-16 For the determination of human E antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08437014205138 - DG Gel 8 Anti-c: 2025-04-16 For the determination of human c antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08437014205145 - DG Gel 8 Anti-e: 2025-04-16 For the determination of human e antigen on the surface of red blood cells of eight human blood samples. For use with the DG Gel
• 08437014205183 - WADiana Compact: 2025-04-16 WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing