BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ARCHITECT CYFRA 21-1 Controls

    Reg #: 2521625 · FEI: 2521625 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Fujirebio Diagnostics, Inc.
    Registration Number
    2521625
    FEI Number
    2521625
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Owner / Operator

    Firm Name
    Fujirebio Diagnostics, Inc.
    Operator Number
    10022860
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Greg Dickson

    Products

    Device Name Product Code
    Cytokeratin Fragments 21-1 Eia Kit OVK

    Proprietary Names

    ARCHITECT CYFRA 21-1 Controls ARCHITECT CYFRA 21-1 Calibrator ARCHITECT CYFRA 21-1 Reagent Alinity i CYFRA 21-1 Reagents Alinity i CYFRA 21-1 Calibrators Alinity i CYFRA 21-1 Controls NSE [FOR USE WITH] Alinity i Controls NSE [FOR USE WITH] Alinity i Reagent NSE [FOR USE WITH] Alinity i Calibrators NSE [For Use With ARCHITECT] Calibrators NSE [For Use With ARCHITECT] Controls NSE [For Use With ARCHITECT] Reagent

    Establishment Types

    Manufacture Device in the United States for Export Only