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Cascadion™ SM 25-Hydroxy Vitamin D Control 2

FDA UDIEUDAMED

Class II (US FDA UDI)

by Thermo Fisher Scientific

Identity

Trade Name
Cascadion™ SM 25-Hydroxy Vitamin D Control 2 FDA UDI
Generic Name
Multiple form 25-hydroxy Vitamin D IVD, control 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. 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. 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. 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. FDA UDI

Identifiers

Catalog Number
10026929 FDA UDI
Primary DI / UDI-DI
06438153007265 FDA UDI
FDA Product Code
PSL FDA UDI
GMDN Term
Multiple form 25-hydroxy Vitamin D IVD, control 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 Control 2 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

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Manufacturer

Manufacturer
Thermo Fisher Scientific

Sources (2)

  • FDA UDI 2e96ac4d-3566-4f1e-949a-1a02ba275612 36 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026