| Primary Device ID | 08437014205183 |
| NIH Device Record Key | d70b72e8-10ad-4e02-ab86-76ecd031341c |
| Commercial Distribution Discontinuation | 2025-04-15 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | WADiana Compact |
| Version Model Number | 213789 |
| Catalog Number | 213789 |
| 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 |
| 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 | 2025-04-16WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana Compact analyzer automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. |
| 08437014205183 - WADiana Compact | 2025-04-16 WADiana Compact is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing |
| 08437014205237 - DG Gel 8 Rh Pheno | 2025-04-16 The DG Gel 8 Rh Pheno card is for the determination of human C, E, c, and e antigens on the surface of red blood cells of two se |