| Primary Device ID | 08437014205176 |
| NIH Device Record Key | f88f72df-bb48-4d71-a16b-0ad3772d8c39 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DG Reader |
| Version Model Number | 213779 |
| Catalog Number | 213779 |
| 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 |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com | |
| Phone | (800)452-6877 |
| service.americas@girfols.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437014205176 [Primary] |
| PBC | Manual Blood Grouping And Antibody Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2022-09-16 |
| Device Publish Date | 2016-09-06 |
| 08436583731215 - Blood Typing Manager | 2023-08-30 Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology |
| 08437014205244 - Grifols Diluent | 2023-06-02 Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards. |
| 08436583730980 - Blood Typing Manager | 2022-12-01 Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology |
| 08436583731024 - DG Gel 8 Anti-D | 2022-10-18 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 |
| 08436583731031 - DG Gel 8 Anti-AB | 2022-10-18 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 |
| 08436583731055 - DG Gel 8 Anti-C | 2022-10-18 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 |
| 08436583731062 - DG Gel 8 Anti-E | 2022-10-18 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 |
| 08436583731079 - DG Gel 8 Anti-c | 2022-10-18 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 |