BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set

    DI: 06438153007241 · Model: NONE · Thermo Fisher Scientific Oy
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set
    Primary DI
    06438153007241
    Version / Model
    NONE
    Catalog Number
    10026927
    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
    e7baf2ba-021e-4b7b-853c-cf8383602c7b
    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 Calibrators are for the calibration 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
    PSL 25-Oh-Vitamin D Mass Spectrometry Test System

    GMDN Terms

    Code Name
    54474 Multiple form 25-hydroxy Vitamin D IVD, calibrator

    Identifiers

    Type ID
    Primary 06438153007241

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -25 – -15 Degrees Celsius