BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AllTest Fentanyl Urine Test Cassette (Home Test)

    Reg #: 1063851 · FEI: 1000442352 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MERCEDES MEDICAL LLC
    Registration Number
    1063851
    FEI Number
    1000442352
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12210 Rangeland Parkway
    City
    Lakewood Ranch
    State
    FL
    ZIP
    34211
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233417

    Owner / Operator

    Firm Name
    MERCEDES MEDICAL LLC
    Operator Number
    9033351
    Address
    12210 Rangeland Parkway, --
    City
    Lakewood Ranch
    State
    FL
    Postal Code
    34211
    Country
    US
    Correspondent
    Misty - McWhorter

    Products

    Device Name Product Code
    Test, Opiates, Over The Counter NGL
    Enzyme Immunoassay, Opiates DJG

    Proprietary Names

    AllTest Fentanyl Urine Test Cassette (Home Test)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198