BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LetsGetChecked Inc.

    Reg #: 3020139194 · FEI: 3020139194 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    LetsGetChecked Inc.
    Registration Number
    3020139194
    FEI Number
    3020139194
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    10825 7th Street, Suite A
    City
    Cucamonga
    State
    CA
    ZIP
    91730
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200070

    Owner / Operator

    Firm Name
    LetsGetChecked Inc.
    Operator Number
    10056783
    Address
    PrivaPath Diagnostics Ltd t/a Lets Get Checked 3rd Floor, Block 1, West Pier Business Campus,, Dun Laoghaire Co.Dublin A96 F8C0
    City
    Dublin
    State
    IE-D
    Postal Code
    A96 F8C0
    Country
    IE
    Correspondent
    Karen Walsh

    Products

    Device Name Product Code
    Test, Vaginal, Bacterial Sialidase MXB
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Urine Collection Kit (Excludes Hiv Testing) OIE
    System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home QYA
    Container, Specimen Mailer And Storage, Sterile KDT
    Container, Specimen Mailer And Storage, Non-Sterile NNK

    Proprietary Names

    LetsGetChecked Vaginal Sample Collection Kit LetsGetChecked Blood Sample Collection Kit LetsGetChecked Blood and Saliva Collection Kit LetsGetChecked Urine Sample Collection Kit Simple 2 Test LetsGetChecked Multisite Sample Collection Kit LetsGetChecked Stool Sample Collection Kit LetsGetChecked Saliva Sample Collection Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198