BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ASI RPR Test for Syphilis for Use on the ASI Evolution

    DI: 00816057021680 · Model: NC-9004800ABB · ARLINGTON SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ASI RPR Test for Syphilis for Use on the ASI Evolution
    Primary DI
    00816057021680
    Version / Model
    NC-9004800ABB
    Catalog Number
    NC-9004800ABB
    Company Name
    ARLINGTON SCIENTIFIC, INC.
    Labeler DUNS
    785966607
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-19
    Public Version
    1
    Public Version Date
    2023-12-27
    Public Version Status
    New
    Public Device Record Key
    0d358595-252c-4814-bcdf-90848e964e8c

    Device Description

    Syphilis Screening Test for Use on the ASI Evolution Analyzer. 4800 test kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    Yes
    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 00816057021680

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius