BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Ionify CalSet Steroids and Vitamin D

    DI: 07613336232156 · Model: 09637273160 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Ionify CalSet Steroids and Vitamin D
    Primary DI
    07613336232156
    Version / Model
    09637273160
    Catalog Number
    09637273160
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-06-25
    Public Version
    1
    Public Version Date
    2025-07-03
    Public Version Status
    New
    Public Device Record Key
    9832a5a7-a8fa-472c-83a6-e7f357ed68fa

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    JIX Calibrator, multi-analyte mixture

    GMDN Terms

    Code Name
    42786 Multiple steroid hormone IVD, calibrator

    Identifiers

    Type ID
    Primary 07613336232156