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
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
| 08437014205152 - DG Spin | 2025-04-29 DG SPIN Centrifugue is a device specifically designed to centrifuge DG Gel 8 cards. |
| 08437014205169 - DG Therm | 2025-04-29 DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology |
| 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 |
Trademark Results [Erytra Eflexis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERYTRA EFLEXIS 79179627 5015283 Live/Registered |
GRIFOLS WORLDWIDE OPERATIONS LIMITED 2015-11-03 |
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