| Primary Device ID | 04015630939305 |
| NIH Device Record Key | 15e7fb66-6978-40c0-943d-72458d3b950a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elecsys SHBG |
| Version Model Number | 3052001160 |
| Catalog Number | 3052001160 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04015630939305 [Primary] |
| CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-28 |
| Device Publish Date | 2021-01-20 |
| 07613336235508 - Bilirubin Total Gen.3 | 2025-02-12 |
| 07613336235515 - Bilirubin Total Gen.3 | 2025-02-10 |
| 07613336235522 - Bilirubin Total Gen.3 | 2025-02-10 |
| 07613336226803 - IRON Gen.2 | 2025-01-22 |
| 07613336182994 - PreciControl Release HBsAg II | 2024-11-15 |
| 07613336228456 - Elecsys HBsAg II | 2024-11-15 |
| 07613336183137 - Elecsys HBsAg II Auto Confirm | 2024-11-15 |
| 07613336183168 - PreciControl HBsAg II | 2024-11-15 |