| Primary Device ID | 04015630925025 |
| NIH Device Record Key | 24387900-6331-4e38-99ad-6596b206358a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Glucose HK Gen3 |
| Version Model Number | 5168791190 |
| Catalog Number | 5168791190 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630925025 [Primary] |
| CFR | HEXOKINASE, GLUCOSE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-07-06 |
| Device Publish Date | 2016-09-20 |
| 07613336218426 - Elecsys Prolactin II | 2024-10-16 |
| 07613336160367 - Elecsys Anti-HBs II | 2024-10-10 |
| 07613336230367 - Elecsys Anti-HBs II | 2024-08-28 |
| 07613336217801 - Elecsys FSH | 2024-08-27 |
| 07613336218327 - Elecsys CA 125 II | 2024-08-21 |
| 07613336218464 - Elecsys Toxo IgM | 2024-08-21 |
| 04015630928941 - Homocysteine Calibrator Kit | 2024-08-20 |
| 04015630037025 - cobas b 123 Fluid Pack 400 | 2024-08-07 |