| Primary Device ID | 04015630972227 |
| NIH Device Record Key | e8d85a32-eddf-46c4-a5e9-18169802498c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody |
| Version Model Number | 05278384001 |
| Catalog Number | 05278384001 |
| Company DUNS | 184042521 |
| Company Name | Ventana Medical Systems, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |