| Primary Device ID | 04015630970094 |
| NIH Device Record Key | e03d0e8b-33fd-467f-8a19-28dec11232e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VENTANA ALK D5F3 CDx Assay |
| Version Model Number | 50 tests |
| Catalog Number | 06687199001 |
| Company DUNS | 184042521 |
| Company Name | Ventana Medical Systems, Inc. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |