BEUDAMED
    FDA Registration Active 🇺🇸 United States

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

    Reg #: 1226774 · FEI: 3003407015 · 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
    1226774
    FEI Number
    3003407015
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    221 US Route 1
    City
    Cumberland Foreside
    State
    ME
    ZIP
    04110
    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

    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