BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuDiag ™

    DI: 00894175000893 · Model: DACD3149-18 · Diagnostic Automation, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AccuDiag ™
    Primary DI
    00894175000893
    Version / Model
    DACD3149-18
    Catalog Number
    3149-18
    Company Name
    Diagnostic Automation, Inc.
    Labeler DUNS
    878252071
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-06-14
    Public Version
    1
    Public Version Date
    2023-06-22
    Public Version Status
    New
    Public Device Record Key
    da176cf4-7cac-487f-b240-5ccf0c846403

    Device Description

    AccuDiag ™ T4 ELISA Kit For the quantitative determination of the Total Thyroxine (T4) concentration in human serum.

    Device Characteristics

    Single Use
    Yes
    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

    GMDN Terms

    Code Name
    58323 Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00894175000893

    Customer Contacts

    Phone
    818-591-3030
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Fahrenheit