BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intercept Oral Fluid Test Specimen Collection Device

    Reg #: 3022474803 · FEI: 3022474803 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORASURE TECHNOLOGIES, INC.
    Registration Number
    3022474803
    FEI Number
    3022474803
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2685 Opus Way, --
    City
    Bethlehem
    State
    PA
    ZIP
    18020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K011057

    Owner / Operator

    Firm Name
    ORASURE TECHNOLOGIES, INC.
    Operator Number
    9000083
    Address
    220 EAST FIRST STREET, --
    City
    Bethlehem
    State
    PA
    Postal Code
    18015
    Country
    US
    Correspondent
    Tiffany A Miller

    Products

    Device Name Product Code
    Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device PJD

    Proprietary Names

    Intercept Oral Fluid Test Specimen Collection Device

    Establishment Types

    Manufacture Medical Device