BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UC5 product codes 705au, 705bcc, 705db, 705ri, 705ro, 705vt

    Reg #: 1226774 · FEI: 3003407015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    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
    K050504

    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

    UC5 product codes 705au, 705bcc, 705db, 705ri, 705ro, 705vt VALIDATE UC4 Urine Chemistry Verification Test Set OSMO product code 703 VALIDATE Urine Chemistry Calibration Verification Test Set VALIDATE UC1 Urine Chemistry Verification Test Set VALIDATE OSMO Urine Chemistry Verification Test Set UC1 product codes 701au, 701bc, 701db, 701ri, 701ro, 701vt VALIDATE UC6 Urine Chemistry Verification Test Set UC4 product codes 704au, 704bc, 704db, 704ri, 704ro UC6 product code 706af VALIDATE UC5 Urine Chemistry Verification Test Set

    Establishment Types

    Manufacture Medical Device