BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SPOTCHECK

    DI: 00725609000649 · Model: 85-4000-05K · ASTORIA-PACIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SPOTCHECK
    Primary DI
    00725609000649
    Version / Model
    85-4000-05K
    Catalog Number
    85-4000-05K
    Company Name
    ASTORIA-PACIFIC, INC.
    Labeler DUNS
    623238615
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-17
    Public Version
    1
    Public Version Date
    2020-12-25
    Public Version Status
    New
    Public Device Record Key
    e8bf5835-1106-40fe-80bb-0adf941138e1

    Device Description

    T4 Neonatal Screening Kit, 480 Test; An Enzyme Immunoassay (EIA) for the Quantitative Determination of Thyroxine (T4) Levels in Neonates

    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

    GMDN Terms

    Code Name
    59219 Neonatal thyroxine (neonatal T4) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00725609000649

    Premarket Submissions

    Submission Number Supplement Number
    K972974 000