| Primary Device ID | 07613336129487 |
| NIH Device Record Key | 87a8089d-39db-4f5d-bfcd-74b92ee22879 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas® vivoDx System |
| Version Model Number | 08082464001 |
| Catalog Number | 08082464001 |
| Company DUNS | 071674100 |
| Company Name | Roche Molecular 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |