| Primary Device ID | 07613336182994 |
| NIH Device Record Key | f133335a-89a8-4bb1-8f7f-bc81c3903a6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PreciControl Release HBsAg II |
| Version Model Number | 09366717190 |
| Catalog Number | 09366717190 |
| 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 | 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 | 07613336182994 [Primary] |
| QHM | Serology tests used for infectious disease screening of blood and plasma donations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-15 |
| Device Publish Date | 2024-11-07 |
| 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 |
| 07613336183229 - PreciControl HIV; HIV-2+GrpO | 2025-02-27 |
| 07613336182970 - PreciControl Release Anti-HCV | 2025-02-26 |
| 07613336183014 - PreciControl Release HTLV | 2025-02-26 |
| 07613336183021 - PreciControl Release Anti-HBc II | 2025-02-26 |