BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Oragene Dx (OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675)

    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
    K192920

    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
    Dna Specimen Collection, Saliva OYJ

    Proprietary Names

    Oragene Dx (OGD-500, OGD-510, OGD-575, OGD-600, OGD-610, OGD-675)

    Establishment Types

    Repack or Relabel Medical Device