BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Simple 2 Test

    Reg #: 3014267096 · FEI: 3014267096 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LetsGetChecked Inc.
    Registration Number
    3014267096
    FEI Number
    3014267096
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1845 Steinway Street, Astoria
    City
    Astoria
    State
    NY
    ZIP
    11105
    Country
    US

    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

    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

    Complaint File Establishment per 21 CFR 820.198