BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PreciControl HBsAg Auto Confirm

    DI: 07613336183236 · Model: 08741107162 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PreciControl HBsAg Auto Confirm
    Primary DI
    07613336183236
    Version / Model
    08741107162
    Catalog Number
    08741107162
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-07
    Public Version
    2
    Public Version Date
    2025-10-24
    Public Version Status
    Update
    Public Device Record Key
    6b7bf8f0-bb80-4d5b-99f3-8e075dd24bfe

    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
    No
    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

    GMDN Terms

    Code Name
    42000 Hepatitis B virus surface antigen IVD, control

    Identifiers

    Type ID
    Primary 07613336183236