BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EL-ANA PROFILES: EL-ANAscr

    DI: 00854473003002 · Model: 100-002 · 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: EL-ANAscr
    Primary DI
    00854473003002
    Version / Model
    100-002
    Catalog Number
    100-002
    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
    6cde720f-97c4-4645-a035-e9fba953a710

    Device Description

    ANTI-NUCLEAR ANTIBODY SCREEN 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
    54850 Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00854473003002

    Premarket Submissions

    Submission Number Supplement Number
    K954106 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius