BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Human Cardiac Troponin I ELISA

    Reg #: 2025099 · FEI: 3007981058 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Biomerica
    Registration Number
    2025099
    FEI Number
    3007981058
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    17571 Von Karman Ave
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US

    Regulatory Submissions

    510(k) Number
    K013062

    Owner / Operator

    Firm Name
    Biomerica, Inc.
    Operator Number
    10023649
    Address
    17571 Von Karman Ave
    City
    Irvine
    State
    CA
    Postal Code
    92614
    Country
    US

    Products

    Device Name Product Code
    Immunoassay Method, Troponin Subunit MMI

    Proprietary Names

    Human Cardiac Troponin I ELISA

    Establishment Types

    Repack or Relabel Medical Device