BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    COBAS AMPLICOR HIV-1 Monitor Test, version 1.5

    DI: 00875197000993 · Model: 2 · Roche Molecular Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COBAS AMPLICOR HIV-1 Monitor Test, version 1.5
    Primary DI
    00875197000993
    Version / Model
    2
    Catalog Number
    03155935018
    Company Name
    Roche Molecular Systems, Inc.
    Labeler DUNS
    071674100
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-17
    Public Version
    3
    Public Version Date
    2020-11-24
    Public Version Status
    Update
    Public Device Record Key
    fc75b6c4-1ae5-448f-b364-f53b15145d76
    Distribution End Date
    2018-09-26

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    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

    Product Codes

    Code Name
    MTL MONITOR,TEST,HIV-1

    GMDN Terms

    Code Name
    30768 HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 00875197000993