BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANA DETECT

    DI: 04260157080638 · Model: ORG600 · ORGENTEC Diagnostika GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANA DETECT
    Primary DI
    04260157080638
    Version / Model
    ORG600
    Catalog Number
    ORG600
    Company Name
    ORGENTEC Diagnostika GmbH
    Labeler DUNS
    328133103
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d4edd7eb-5c4a-4d3b-97ea-9e7abeecdffb

    Device Description

    ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    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
    54809 Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04260157080638

    Customer Contacts

    Phone
    +49061319258
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K030929 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius