BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KRONUS, INC.

    Reg #: 2025560 · FEI: 2025560 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    KRONUS, INC.
    Registration Number
    2025560
    FEI Number
    2025560
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    170 S. Seneca Springs Way, Suite 105
    City
    Star
    State
    ID
    ZIP
    83669
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051061

    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
    Autoantibodies, Glutamic Acid Decarboxylase (Gad) NWG
    21-Hydroxylase Antibody (21-Ohab) PCG
    Aquaporin-4 Autoantibody PNI
    Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking NST
    Tyrosine Phosphatase (Ia-2) Autoantibody Assay OIF
    System, Test, Thyroid Autoantibody JZO
    Insulin Autoantibody Kit OCN
    Zinc Transporter 8 Auto-Antibody PHF
    System, Test, Thyroglobulin MSW
    Voltage Gated Calcium Channel (Vgcc) Antibody Assay PAF

    Proprietary Names

    KRONUS GLUTAMIC ACID DEC Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay KRONUS TRAb CT

    Establishment Types

    Repack or Relabel Medical Device