BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Simple 2 Test

    Reg #: 3015209536 · FEI: 3015209536 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Privapath Diagnostics Ltd
    Registration Number
    3015209536
    FEI Number
    3015209536
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit 1, Northern Cross Business Park, North Road
    City
    Dublin 11
    Country
    IE

    Regulatory Submissions

    510(k) Number
    DEN200070

    Owner / Operator

    Firm Name
    LetsGetChecked Inc.
    Operator Number
    10056783
    Address
    Unit 6 Adelphi House
    City
    George's Street Upper, Dún Laoghaire
    State
    Dublin
    Postal Code
    A96 NY82
    Country
    IE
    Correspondent
    Karen Walsh

    US Agent

    Business Name
    NDA Partners, a ProPharma Company
    Contact Name
    Erica Berzin, MS
    Address
    1129 20th St NW, Suite 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    202 7382550

    Products

    Device Name Product Code
    System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home QYA

    Proprietary Names

    Simple 2 Test

    Establishment Types

    Manufacture Medical Device