| Primary Device ID | 07613336121603 |
| NIH Device Record Key | 9fdbd14f-499e-429e-9f34-2aec60212b4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Urea/Bun |
| Version Model Number | 08058806190 |
| Catalog Number | 08058806190 |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613336121603 [Primary] |
| CDQ | UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-13 |
| Device Publish Date | 2020-03-05 |
| 07613336227763 - Sodium electrode | 2025-03-13 |
| 07613336227770 - Potassium electrode | 2025-03-13 |
| 07613336227787 - Chloride electrode | 2025-03-13 |
| 07613336227794 - Reference electrode | 2025-03-13 |
| 07613336183045 - PreciControl Release HIV Gen II | 2025-02-27 |
| 07613336228487 - Elecsys Anti-HBc II | 2025-02-27 |
| 07613336228500 - Elecsys HIV Duo | 2025-02-27 |
| 07613336183212 - PreciControl HIV Gen II | 2025-02-27 |