| Primary Device ID | 07613336232132 |
| NIH Device Record Key | 20e4d626-1bec-401d-a2ab-b903d96fd20d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ionify Steroids 2 |
| Version Model Number | 09634444160 |
| Catalog Number | 09634444160 |
| 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 | 07613336232132 [Primary] |
| JKC | RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-19 |
| Device Publish Date | 2025-12-11 |
| 07613336232125 - Ionify Steroids 1 | 2025-12-19 Ionify Estradiol Ionify Androstenedione |
| 07613336232132 - Ionify Steroids 2 | 2025-12-19Ionify DHEA Ionify DHEA-S Ionify 17-Hydroxyprogesterone Ionify Progesterone |
| 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 |
| 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 |