BEUDAMED
    FDA Registration Active 🇺🇸 United States

    THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY

    Reg #: 3008583799 · FEI: 3008583799 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CLIAWAIVED,INC.
    Registration Number
    3008583799
    FEI Number
    3008583799
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2721 Loker Ave W
    City
    Carlsbad
    State
    CA
    ZIP
    92010
    Country
    US

    Regulatory Submissions

    510(k) Number
    K990658

    Owner / Operator

    Firm Name
    Cliawaived, Inc.
    Operator Number
    10035746
    Address
    2721 Loker Ave West
    City
    Carlsbad
    State
    CA
    Postal Code
    92010
    Country
    US
    Correspondent
    Tim Drapeau

    Products

    Device Name Product Code
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW

    Proprietary Names

    THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility