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    FDA Registration Active 🇺🇸 United States

    Validate CM2 product code 402ab

    Reg #: 1226774 · FEI: 3003407015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    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

    Regulatory Submissions

    510(k) Number
    K090475

    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 CM2 product code 402ab CM2 Calibration Verification/Linear Validate CM2vt Calibration Verification Linearity Test Kit, product code 402vt VALIDATE CM2 Calibration Verification/Linearity Test Set Validate CM2 product code 402re Validate CM2 product code 402bc Validate hsCRP Calibration Verification Linearity Test Kit product code 404ro

    Establishment Types

    Manufacture Medical Device