BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IDS-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set

    Reg #: 3007118747 · FEI: 3007118747 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    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

    Regulatory Submissions

    510(k) Number
    K111938

    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-iSYS Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Control Set IDS-iSYS Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Calibration Verifiers IDS-iSYS Human Growth Hormone (hGH) Calibration Verifiers

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198