BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Validate PSA product code 406bc

    Reg #: 1226774 · FEI: 3003407015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    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
    K123127

    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
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX

    Proprietary Names

    Validate PSA product code 406bc Validate PSA product code 406re VALIDATE PSA Calibration Verification/Linearity Test Kit

    Establishment Types

    Manufacture Medical Device