Vitamin D 200 Series
13 catalogue numbers from 5045352, listed by Ab Sciex, LLC, United States, under 25-Oh-Vitamin D Mass Spectrometry Test System. 1 manufacturer in China is registered for this product code.
1manufacturer
13catalogue numbers in this listing
1510(k) clearance
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 | Ab Sciex, LLC, United States |
|---|---|
| FDA product code | PSL |
| Device type | 25-Oh-Vitamin D Mass Spectrometry Test System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1840 |
| Record published | 2017-11-06 |
| Record revised | 2020-08-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 3, pack of 5 |
| Distribution end date | 2020-07-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5045352 | Withdrawn | |
| 5045356 | Withdrawn | |
| 5044486 | Withdrawn | |
| 5044493 | Withdrawn | |
| 5044485 | Withdrawn | |
| 5044488 | Withdrawn | |
| 5044492 | Withdrawn | |
| 5044487 | Withdrawn | |
| 5045346 | Withdrawn | |
| 5044490 | Withdrawn | |
| 5044489 | Withdrawn | |
| 5045360 | Withdrawn | |
| 5044491 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Ionify Vitamin D 25 | Roche Diagnostics Gmbh | 1 |
| Vitamin D 200M Assay for the TopazTM System | Ab Sciex, LLC | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| DEN170019 | 2017-05-18 |
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.