BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Omega Laboratories Hair Drug Screening Assay

    Reg #: 3004847291 · FEI: 3004847291 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OMEGA LABORATORIES, INC.
    Registration Number
    3004847291
    FEI Number
    3004847291
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 N CLEVELAND AVE
    City
    MOGADORE
    State
    OH
    ZIP
    44260
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131128

    Owner / Operator

    Firm Name
    OMEGA LABORATORIES, INC.
    Operator Number
    9074072
    Address
    400 NORTH CLEVELAND, --
    City
    Mogadore
    State
    OH
    Postal Code
    44260
    Country
    US
    Correspondent
    Bill - Corl

    Products

    Device Name Product Code
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO

    Proprietary Names

    Omega Laboratories Hair Drug Screening Assay

    Establishment Types

    Manufacture Medical Device