BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay), CALEX® Cap (stool preparation device)

    Reg #: 1000191380 · FEI: 1000191380 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BUHLMANN LABORATORIES AG
    Registration Number
    1000191380
    FEI Number
    1000191380
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BASELSTRASSE 55
    City
    SCHONENBUCH/BASEL Basel-Landschaft
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K191718

    Owner / Operator

    Firm Name
    BUHLMANN LABORATORIES AG
    Operator Number
    9023594
    Address
    BASELSTRASSEE 55, --
    City
    SCHONENBUCH/BASEL
    State
    Basel-Landschaft
    Postal Code
    CH-4124
    Country
    CH

    US Agent

    Business Name
    CEO
    Contact Name
    Collin Shaw
    Address
    105 State Route 101A, Suite 1
    City
    Amherst
    State
    NH
    ZIP
    03031
    Country
    US
    Email
    [email protected]
    Phone
    603 7320674 ext. 212

    Products

    Device Name Product Code
    Calprotectin, Fecal NXO

    Proprietary Names

    BUHLMANN fCAL® turbo (fecal calprotectin turbidimetric assay), CALEX® Cap (stool preparation device) fCAL turbo, fCAL Calibrator Set, fCAL Control Set (fecal calprotectin turbidimetric assay), CALEX® Cap

    Establishment Types

    Manufacture Medical Device