BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENA-6Pro ELISA

    Reg #: 1222302 · FEI: 1000121039 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    American Laboratory Products Company
    Registration Number
    1222302
    FEI Number
    1000121039
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    26 Keewaydin Drive, Unit G
    City
    Salem
    State
    NH
    ZIP
    03079
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032469

    Owner / Operator

    Firm Name
    AMERICAN LABORATORY PRODUCTS CO., LTD.
    Operator Number
    9000664
    Address
    26 KEEWAYDIN DR., BLDG- G
    City
    Salem
    State
    NH
    Postal Code
    03079
    Country
    US
    Correspondent
    James Richard

    Products

    Device Name Product Code
    Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls LJM
    Extractable Antinuclear Antibody, Antigen And Control LLL

    Proprietary Names

    ENA-6Pro ELISA ANA-8Pro ELISA

    Establishment Types

    Repack or Relabel Medical Device