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    FDA UDI In Commercial Distribution 🇺🇸 United States

    EL-ANA Profiles: anti-Centromere

    DI: 00854473003170 · Model: 104-111 · 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-Centromere
    Primary DI
    00854473003170
    Version / Model
    104-111
    Catalog Number
    104-111
    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
    4b16dec8-9ba9-41d9-a7d1-b33b911eeab3

    Device Description

    ANTI-CENTROMERE 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
    54889 Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00854473003170

    Premarket Submissions

    Submission Number Supplement Number
    K024031 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius