BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuDiag ™

    DI: 00894175000213 · Model: DACD-2555-2 · 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
    00894175000213
    Version / Model
    DACD-2555-2
    Catalog Number
    2555-2
    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
    b9138d6e-e560-4b88-a7a3-37c9e93a31cc

    Device Description

    AccuDiag ™ SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) The SS-A Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSA or anti-Ro antibodies (Sjogren's antibodies) in a clinical specimen, using an enzyme immunoassay (EIA) method.

    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

    GMDN Terms

    Code Name
    55129 SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00894175000213

    Customer Contacts

    Phone
    8185913030
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Size Type Text Device Size Text, specify: 96 Tests

    Storage Conditions

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