| Primary Device ID | 07613336232156 |
| NIH Device Record Key | 9832a5a7-a8fa-472c-83a6-e7f357ed68fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ionify CalSet Steroids and Vitamin D |
| Version Model Number | 09637273160 |
| Catalog Number | 09637273160 |
| 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 | 07613336232156 [Primary] |
| JIX | Calibrator, multi-analyte mixture |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-03 |
| Device Publish Date | 2025-06-25 |
| 07613336232156 - Ionify CalSet Steroids and Vitamin D | 2025-07-03 |
| 07613336232156 - Ionify CalSet Steroids and Vitamin D | 2025-07-03 |
| 07613336232194 - Ionify ControlSet Steroids and Vitamin D | 2025-07-03 |
| 07613336232149 - Ionify Vitamin D 25 | 2025-06-12 |
| 04015630924288 - sFlT-1 CalSet | 2025-04-15 |
| 04015630925407 - CalSet PlGF | 2025-04-15 |
| 07613336172094 - Elecsys sFlT-1 | 2025-04-15 |
| 07613336172124 - Elecsys PlGF | 2025-04-15 |
| 07613336220108 - PreciControl Rubella IgM | 2025-04-15 |