BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMPACT RPR™ TEST KIT (5000 TESTS)

    DI: 10859035006061 · Model: 60C4 · ALERE NORTH AMERICA, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    5000

    Basic Information

    Brand Name
    IMPACT RPR™ TEST KIT (5000 TESTS)
    Primary DI
    10859035006061
    Version / Model
    60C4
    Company Name
    ALERE NORTH AMERICA, LLC
    Labeler DUNS
    826027364
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5000
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    86e692bc-fb7e-4d37-b740-07e057908318

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    GMQ Antigens, Nontreponemal, All

    GMDN Terms

    Code Name
    51819 Treponema pallidum reagin antibody IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 10859035006061
    Unit of Use 00859035006064

    Customer Contacts

    Phone
    1-877-441-7440
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius