Ionify Vitamin D 25
Ionify 25-Hydroxy Vitamin D total
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | PSL |
| Device type | 25-Oh-Vitamin D Mass Spectrometry Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1840 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-06-04 |
| Record revised | 2025-09-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09634622160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitamin D 200 Series | Ab Sciex, LLC | 13 |
| Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set | Thermo Fisher Scientific OY | 1 |
| Cascadion™ SM 25-Hydroxy Vitamin D Control 2 | Thermo Fisher Scientific OY | 1 |
| Cascadion™ SM 25-Hydroxy Vitamin D Control 3 | Thermo Fisher Scientific OY | 1 |
| Cascadion™ SM 25-Hydroxy Vitamin D Control 1 | Thermo Fisher Scientific OY | 1 |
| Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard | Thermo Fisher Scientific OY | 1 |
| Vitamin D 200M Assay for the TopazTM System | Ab Sciex, LLC | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.