BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accutrend Cholesterol Controls

    DI: 00365702250109 · Model: 5219957001 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Accutrend Cholesterol Controls
    Primary DI
    00365702250109
    Version / Model
    5219957001
    Catalog Number
    5219957001
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-01-18
    Public Version
    1
    Public Version Date
    2021-01-26
    Public Version Status
    New
    Public Device Record Key
    0f4a8664-c3ba-4169-9e55-698a7e8d35a1

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    Yes
    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
    JJX Single (specified) analyte controls (assayed and unassayed)

    GMDN Terms

    Code Name
    44697 Total cholesterol lipid IVD, control

    Identifiers

    Type ID
    Primary 00365702250109