BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    First To Know Syphilis Test

    DI: 00858022006001 · Model: 8057-1 · NOWDIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    First To Know Syphilis Test
    Primary DI
    00858022006001
    Version / Model
    8057-1
    Catalog Number
    8057-1
    Company Name
    NOWDIAGNOSTICS, INC.
    Labeler DUNS
    079541513
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-11-11
    Public Version
    1
    Public Version Date
    2024-11-19
    Public Version Status
    New
    Public Device Record Key
    386722af-8418-41ea-ae6e-1b3f24ef606e

    Device Description

    Inner package containing one-count device

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    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
    SBZ Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users

    GMDN Terms

    Code Name
    66561 Treponema pallidum total antibody IVD, kit, rapid ICT, self-testing

    Identifiers

    Type ID
    Primary 00858022006001

    Premarket Submissions

    Submission Number Supplement Number
    DEN230090 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    15 – 30 Degrees Celsius