BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VALIDATE GC3 Calibration verification/linearity test kit, product codes: 1300wa

    Reg #: 3007088335 · FEI: 1220394 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LGC Clinical Diagnostics, Inc.
    Registration Number
    3007088335
    FEI Number
    1220394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    37 Birch St
    City
    Milford
    State
    MA
    ZIP
    01757
    Country
    US

    Owner / Operator

    Firm Name
    LGC Clinical Diagnostics, Inc.
    Operator Number
    9041170
    Address
    37 Birch Street, --
    City
    Milford
    State
    MA
    Postal Code
    01757
    Country
    US
    Correspondent
    RAY - BANDZIULIS

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY

    Proprietary Names

    VALIDATE GC3 Calibration verification/linearity test kit, product codes: 1300wa VALIDATE Fertility 2 Calibration Verification/Linearity Test Kit, product code: 504ab, 504re VALIDATE GC1 Calibration verification/linearity test kit, product codes: 1100wa VALIDATE SP2 Calibration verification/linearity test kit, product codes: 602bc, 602re VALIDATE Fertility 1 Calibration Verification/Linearity Test Kit, product code: 502ab, 502re VALIDATE Body Fluids Calibration Verification/Linearity Test Kit, product codes: 205bf, 205ro VALIDATE ISx Calibration Verification/Linearity Test Kit, product code: 608mm VALIDATE Anemia Calibration verification/linearity test kit, product codes: 308ab, 308bc, 308re, 308vt VALIDATE UC4 Calibration Verification/Linearity Test Kit, product code: 704ab, 704sa VALIDATE CM3 Calibration verification/linearity test kit, product code: 409ro VALIDATE Tumor Markers Calibration Verification/Linearity Test Kit, product codes: 407ab, 407re, 407sa VALIDATE Body Fluids 2 Calibration Verification/Linearity Test Kit, product code: 206ro VALIDATE High Sensitive Troponin Calibration Verification/Linearity Test Kit, product code 405ro VALIDATE SP1 Calibration Verification/Linearity Test Kit, product code: 601ro VALIDATE SP3 Calibration verification/linearity test kit, product code: 603ro VALIDATE LP2 Calibration Verification/Linearity Test Kit, product code: 507ro VALIDATE THY2 Hormone Calibration Verification/Linearity Test Kit, product code:908bc VALIDATE® LCMS VIT D Test Kit, product code: 1001ro VALIDATE Diabetes Calibration Verification/Linearity Test Kit, product code: 204ro VALIDATE IBC Calibration Verification/Linearity Test Kit, product codes: 203ro, 203sd, 203vt VALIDATE CM1 Calibration verification/linearity test kit, product code: 401ro VALIDATE Fertility 3 Calibration Verification/Linearity Test Kit, product code: 505ro VALIDATE UC5 Calibration Verification/Linearity Test Kit, product code: 705ab VALIDATE THY Calibration verification/linearity test kit, product codes: 901ab VALIDATE Tumor Markers 2 Calibration Verification/Linearity Test Kit, product code: 408re VALIDATE Body Fluids 3 Calibration Verification/Linearity Test Kit, product code: 207ro VALIDATE® CM2 Calibration Verification / Linearity Test Set (Product Code 402pf) VALIDATE UC1 Calibration Verification/Linearity Test Kit, product code: 701ab, 701re, 701sa VALIDATE LCMS Steroids Calibration Verification/Linearity Test Kit, product code: 1003ro

    Establishment Types

    Manufacture Medical Device