BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IMMUNOSCAN CCPlus

    DI: 07340058410868 · Model: RA-96PLUS · Euro-Diagnostica AB
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IMMUNOSCAN CCPlus
    Primary DI
    07340058410868
    Version / Model
    RA-96PLUS
    Catalog Number
    RA-96PLUS
    Company Name
    Euro-Diagnostica AB
    Labeler DUNS
    559894501
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-12
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6ecacd75-3155-44e7-87d2-295c736265af

    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

    Product Codes

    Code Name
    NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

    GMDN Terms

    Code Name
    54896 Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 07340058410868

    Premarket Submissions

    Submission Number Supplement Number
    K091657 000