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.

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

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