| Primary Device ID | 07613336149881 |
| NIH Device Record Key | 81390893-051a-4ad9-86d9-c069b739569e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PreciControl Total-Tau |
| Version Model Number | 07357028190 |
| Catalog Number | 07357028190 |
| 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 | 07613336149881 [Primary] |
| JJX | Single (specified) analyte controls (assayed and unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-21 |
| Device Publish Date | 2023-08-11 |
| 04015630939114 - Elecsys BRAHMS PCT | 2026-02-09 |
| 04015630940073 - Elecsys BRAHMS PCT | 2026-02-09 |
| 07613336224281 - PreciControl Rubella IgG | 2026-02-05 |
| 07613336206737 - VENTANA DP 600 slide scanner | 2025-12-23 |
| 07613336232125 - Ionify Steroids 1 | 2025-12-19 Ionify Estradiol Ionify Androstenedione |
| 07613336232132 - Ionify Steroids 2 | 2025-12-19 Ionify DHEA Ionify DHEA-S Ionify 17-Hydroxyprogesterone Ionify Progesterone |
| 07613336216958 - CalSet Phospho-Tau (181P) Plasma | 2025-11-26 |
| 07613336216965 - PreciControl Phospho-Tau (181P) Plasma | 2025-11-26 |