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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuDiag ™

    DI: 00894175000008 · Model: DACD-351010 · 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
    00894175000008
    Version / Model
    DACD-351010
    Catalog Number
    351010
    Company Name
    Diagnostic Automation, Inc.
    Labeler DUNS
    878252071
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-06
    Public Version
    1
    Public Version Date
    2021-08-16
    Public Version Status
    New
    Public Device Record Key
    ae2dc8e6-8728-4571-9184-136d4ae42b54

    Device Description

    AccuDiag ™ IFA FTA-ABS Test System - Treponema pallidum total antibody IVD, kit, Fluorescent Immunoassay Fluorescent Treponemal Antibody-Absorption (FTA-ABS) Test System is designed for the qualitative determination of antibodies to Treponema pallidum, and is intended to be used as an aid in the confirmation of syphilis antibodies. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Treponema pallidum in a clinical specimen using a fluorescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.

    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
    GMS Anti-Human Globulin, Fta-Abs Test

    GMDN Terms

    Code Name
    51799 Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 00894175000008

    Customer Contacts

    Phone
    8185913030
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 10x10 wells

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Storage Environment Temperature: between 2 and 8 Degrees Celsius