Devices & Diagnostics > Device

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 Calibrators are for the calibration of the Cascadion SM 25-Hydroxy Vitamin D Assay on the Cascadion SM Clinical Analyzer.


by Thermo Fisher Scientific Oy
Product Overview

The Cascadion™ SM 25
Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set - NONE


Device Description

A material which is used to establish known points of reference for 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.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -15.00
    • -25.00


    • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: PSL

    Device Name: 25-Oh-Vitamin D Mass Spectrometry Test System

    Device Class: 2

    Physical State: Mass spectrometer, liquid chromatography-tandem mass spectrometer

    Definition: A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Liquid chromatography-tandem mass spectrometry (LC-MS/MS), mass spectrometry

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: In vitro diagnostic use

    Regulation Number: 862.1840

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 06438153007241

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.

    GMDN ®. © GMDN Agency 2005-.
    Educational Resources
    Videos