| Primary Device ID | 07613336171394 |
| NIH Device Record Key | 3a04b7b4-5090-4464-ac2e-772080c32531 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tg II CalSet |
| Version Model Number | 08991405190 |
| Catalog Number | 08991405190 |
| Company DUNS | 315028860 |
| Company Name | Roche Diagnostics GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 07613336171394 [Primary] |
| JIT | Calibrator, secondary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
| 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 |
| 07613336183236 - PreciControl HBsAg II Auto Confirm | 2024-11-15 |
| 07613336234402 - navify® Lab Operations | 2024-11-05 |
| 07613336217665 - Elecsys Total PSA | 2024-11-01 |
| 07613336217672 - Elecsys free PSA | 2024-11-01 |