BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    BOND Ready-to-Use (RTU) Primary Antibody, MLH1 (Mismatch Repair Protein) (ES05)

    Reg #: 3004859032 · FEI: 3004859032 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LEICA BIOSYSTEMS NEWCASTLE LTD
    Registration Number
    3004859032
    FEI Number
    3004859032
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BALLIOL BUSINESS PARK WEST, BENTON LANE
    City
    NEWCASTLE UPON TYNE
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K213348

    Owner / Operator

    Firm Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Operator Number
    10054155
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    Postal Code
    60010
    Country
    US
    Correspondent
    Adam Blunier

    US Agent

    Business Name
    Leica Biosystems, division of Leica Microsystems, Inc.
    Contact Name
    Adam Blunier
    Address
    21440 W. Lake Cook Road, Floor 5
    City
    Deer Park
    State
    IL
    ZIP
    60010
    Country
    US
    Email
    [email protected]
    Phone
    630 6340069 ext. 3462

    Products

    Device Name Product Code
    Lynch Syndrome Test System PZJ

    Proprietary Names

    BOND Ready-to-Use (RTU) Primary Antibody, MLH1 (Mismatch Repair Protein) (ES05) BOND Ready-to-Use (RTU) Primary Antibody, MSH6 (Mismatch Repair Protein) (EP49) BOND Ready-to-Use (RTU) Primary Antibody, MSH2 (Mismatch Repair Protein) (79H11) BOND Ready-to-Use (RTU) Primary Antibody, PMS2 (Mismatch Repair Protein) (EP51)

    Establishment Types

    Manufacture Medical Device