BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

    Reg #: 2025560 · FEI: 2025560 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KRONUS, INC.
    Registration Number
    2025560
    FEI Number
    2025560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    170 S. Seneca Springs Way, Suite 105
    City
    Star
    State
    ID
    ZIP
    83669
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220085

    Owner / Operator

    Firm Name
    KRONUS, INC.
    Operator Number
    2025560
    Address
    170 S. Seneca Springs Way, SUITE 105
    City
    Star
    State
    ID
    Postal Code
    83669
    Country
    US
    Correspondent
    HEATHER VIELE

    Products

    Device Name Product Code
    Tyrosine Phosphatase (Ia-2) Autoantibody Assay OIF

    Proprietary Names

    KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

    Establishment Types

    Repack or Relabel Medical Device