Erytra 210401
GUDID 08437014205190
The Erytra is a fully-automated high-throughput analyzer designed to automate in vitro immunohematologial test of human blood utilizing DG Gel 8 card technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Compatability 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| Primary Device ID | 08437014205190 |
| NIH Device Record Key | f7fd9db5-0cba-425a-ba4e-bf40510aae1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Erytra |
| Version Model Number | 210401 |
| Catalog Number | 210401 |
| 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 | 08437014205190 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- BK130067
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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-09-16 |
| Device Publish Date | 2016-09-06 |
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 |
Trademark Results [Erytra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERYTRA 79049656 3543861 Live/Registered |
GRIFOLS, S.A. 2007-12-05 |
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