BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AccuDiag ™

    DI: 00894175000220 · Model: DACD-2556-2 · Diagnostic Automation, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AccuDiag ™
    Primary DI
    00894175000220
    Version / Model
    DACD-2556-2
    Catalog Number
    2556-2
    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
    0f44c923-6651-4753-a9b8-ec4acf97340a

    Device Description

    AccuDiag ™ SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA). A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-SSB or anti-La 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

    GMDN Terms

    Code Name
    55132 SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00894175000220

    Customer Contacts

    Phone
    8185913030
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 96 Tests

    Storage Conditions

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