Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard
Basic Information
- Brand Name
- Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard
- Primary DI
- 06438153007289
- Version / Model
- NONE
- Catalog Number
- 10026958
- Company Name
- Thermo Fisher Scientific Oy
- Labeler DUNS
- 540096708
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-02
- Public Version
- 2
- Public Version Date
- 2023-07-26
- Public Version Status
- Update
- Public Device Record Key
- 166933b0-3bab-412a-896a-e07cd513a863
- Distribution End Date
- 2023-02-22
Device Description
The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 25-Hydroxy Vitamin D (25-OH Vit D) in human serum through the quantitative measurement and combination of 25-Hydroxy Vitamin D3 and 25-Hydroxy Vitamin D2 on the Cascadion™ SM Clinical Analyzer. This liquid-chromatography-tandem mass spectrometry (LC-MS/MS) assay is to be used as an aid in the assessment of Vitamin D sufficiency. This in vitro diagnostic device is intended for clinical laboratory use only. The Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard is used to ensure the accuracy of the assay on the Cascadion™ SM Clinical Analyzer by correcting for systematic and random errors due to variations in sample preparation, chromatography, and detection. The Internal Standard is also used as a precipitating agent in the sample preparation method.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PSL | 25-Oh-Vitamin D Mass Spectrometry Test System | Clinical Chemistry | 862.1840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62018 | Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen, using a liquid chromatography/mass spectrometry (LC/MS) method. It is used in the investigation of conditions associated with vitamin D deficiency and for the assessment of vitamin D status during supplementation therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438153007289 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius