BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Validate GC4 product codes: 1400ab, 1400au, 1400bc, 1400re, 1400ri, 1400sa, 1400sd, 1400vt

    Reg #: 1226774 · FEI: 3003407015 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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
    K091225

    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 GC4 product codes: 1400ab, 1400au, 1400bc, 1400re, 1400ri, 1400sa, 1400sd, 1400vt Validate GC1 product codes:1100ab, 1100au, 1100bc, 1100ri, 1100ro, 1100sa, 1100sd, 1100sv, 1100vt Validate GC1, GC2, GC3 and GC4 Cali Validate GC3 product codes: 1300ab, 1300au, 1300bcc, 1300re, 1300sa, 1300sd, 1300vt Validate GC2 product codes: 1200ab, 1200au, 1200bc, 1200re, 1200sa, 1200sd, 1200vt

    Establishment Types

    Manufacture Medical Device