| Primary Device ID | 07613336158876 |
| NIH Device Record Key | 7484de60-d0f0-434f-a8c4-3e9adac11562 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cobas pro ISE analytical unit |
| Version Model Number | 08464537001 |
| Catalog Number | 08464537001 |
| Company DUNS | 315028860 |
| Company Name | Roche Diagnostics GmbH |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613336158876 [Primary] |
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-16 |
| Device Publish Date | 2020-03-06 |
| 07613336224816 - ONLINE TDM Methotrexate | 2024-04-02 |
| 07613336224823 - ONLINE TDM Methotrexate | 2024-04-02 |
| 07613336224830 - MTX Calibrator | 2024-04-02 |
| 07613336217689 - Elecsys ProBNP II | 2024-02-27 |
| 04015630929702 - cobas Elecsys AntiTPO | 2024-02-16 |
| 04015630939626 - Elecsys Anti-TPO | 2024-02-16 |
| 04015630899548 - Elecsys CalSet TUptake | 2024-02-05 |
| 04015630899579 - Elecsys Tuptake Assay | 2024-02-05 |