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Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard FDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- NONE FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 10026958 FDA UDI
- Primary DI / UDI-DI
- 06438153007289 FDA UDI
- FDA Product Code
- PSL FDA UDI
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, kit, liquid chromatography/mass spectrometry (LC/MS) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1840 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cascadion™ SM 25-Hydroxy Vitamin D Internal Standard by Thermo Fisher Scientific — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific
Sources (2)
- FDA UDI 166933b0-3bab-412a-896a-e07cd513a863 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026