FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cascadion™ SM 25-Hydroxy Vitamin D Control 2
DI: 06438153007265
·
Model: NONE
·
Thermo Fisher Scientific Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cascadion™ SM 25-Hydroxy Vitamin D Control 2
- Primary DI
- 06438153007265
- Version / Model
- NONE
- Catalog Number
- 10026929
- 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
- 2e96ac4d-3566-4f1e-949a-1a02ba275612
- 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. The Cascadion™ SM 25-Hydroxy Vitamin D Controls are for quality control of the Cascadion SM 25-Hydroxy Vitamin D Assay on the Cascadion SM Clinical Analyzer.
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 |
|---|---|---|---|---|
| 54475 | Multiple form 25-hydroxy Vitamin D IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple forms of 25-hydroxy vitamin D in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06438153007265 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius