| Primary Device ID | 04015630924820 |
| NIH Device Record Key | a0eb22fe-2197-41b4-8552-cd619df423b5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Albumin Gen2 |
| Version Model Number | 5166861190 |
| Catalog Number | 5166861190 |
| 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 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630924820 [Primary] |
| CIX | BROMCRESOL GREEN DYE-BINDING, ALBUMIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-20 |
| 04015630924820 | 5166861190 |
| 04015630922581 | 4657357190 |
| 04015630918898 | 3183688122 |