BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CalCheck beta-Amyloid (1-42) II

    DI: 07613336180860 · Model: 06986854190 · 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
    CalCheck beta-Amyloid (1-42) II
    Primary DI
    07613336180860
    Version / Model
    06986854190
    Catalog Number
    06986854190
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-13
    Public Version
    1
    Public Version Date
    2022-12-21
    Public Version Status
    New
    Public Device Record Key
    35c44437-de35-49be-a6fe-72dfac402ac9

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (specified) analyte controls (assayed and unassayed)

    GMDN Terms

    Code Name
    56782 Amyloid B component IVD, control

    Identifiers

    Type ID
    Primary 07613336180860