BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EL-ANA Profiles: anti-dsDNA

    DI: 00854473003026 · Model: 104-201 · THERA-TEST LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EL-ANA Profiles: anti-dsDNA
    Primary DI
    00854473003026
    Version / Model
    104-201
    Catalog Number
    104-201
    Company Name
    THERA-TEST LABORATORIES, INC
    Labeler DUNS
    194336954
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-15
    Public Version
    3
    Public Version Date
    2023-07-07
    Public Version Status
    Update
    Public Device Record Key
    0b906511-2fe0-4743-8697-c16b36f4d0e5

    Device Description

    ANTI-DOUBLE STRANDED DNA ANTIBODY ELISA TEST KIT, 96 TESTS

    Device Characteristics

    Single Use
    No
    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
    54902 Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00854473003026

    Premarket Submissions

    Submission Number Supplement Number
    K051066 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius