| Primary Device ID | 07613336228470 |
| NIH Device Record Key | 9a9ff632-fa9d-46a5-b4f4-5314786771f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elecsys HTLV-I/II |
| Version Model Number | 09015272162 |
| Catalog Number | 09015272162 |
| Company DUNS | 315028860 |
| Company Name | Roche Diagnostics GmbH |
| Device Count | 20 |
| 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 | 07613336183090 [Primary] |
| GS1 | 07613336228470 [Unit of Use] |
| 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 | 2025-02-26 |
| Device Publish Date | 2025-02-18 |
| 07613336231357 - cobas i 601 SBL | 2025-08-18 |
| 07613336231388 - cobas pro i 601 BL | 2025-08-18 |
| 07613336222713 - navify | 2025-08-08 |
| 07613336228630 - HPLC Cartridge (iHPLC) | 2025-08-08 |
| 07613336228647 - Rapid Cartridge B (iRapidB) | 2025-08-08 |
| 07613336228654 - Rapid Cartridge C (iRapidC) | 2025-08-08 |
| 07613336231364 - cobas i 601 | 2025-08-08 |
| 04015630933457 - PreciControl Cortisol Urine | 2025-08-01 |