BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IDS Cortisol Control Set

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EUROIMMUN US INC.
    Registration Number
    3007118747
    FEI Number
    3007118747
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1 Bloomfield Ave
    City
    Mountain Lakes
    State
    NJ
    ZIP
    07046
    Country
    US

    Owner / Operator

    Firm Name
    EUROIMMUN US Inc.
    Operator Number
    10025673
    Address
    1 Bloomfield Ave.
    City
    Mountain Lakes
    State
    NJ
    Postal Code
    07046
    Country
    US

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    IDS Cortisol Control Set IDS SHBG Calibration Verifiers IDS ACTH II Control Set IDS Androstenedione Calibrator Set IDS SHBG Control Set IDS-iSYS Ostase® BAP Control Set IDS-iSYS Free Testosterone Control Set IDS Prolactin Calibrator Set IDS ACTH II Calibrator Set IDS-iSYS Ostase® BAP Calibration Verifiers IDS Beta CrossLaps® (CTX-I) Calibrator Set IDS Cortisol Calibrator Set IDS Androstenedione Control Set IDS Beta CrossLaps® (CTX-I) Control Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198