BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Kitlab RapidGo Flu A/B & Covid-19 Home Test

    Reg #: 3034693280 · FEI: 3034693280 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KITLAB INC
    Registration Number
    3034693280
    FEI Number
    3034693280
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1 Perlman Dr Ste 200
    City
    Spring Valley
    State
    NY
    ZIP
    10977
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN240029

    Owner / Operator

    Firm Name
    Kitlab Inc
    Operator Number
    10092110
    Address
    1 Perlman Dr., Suite 200
    City
    Spring Valley
    State
    NY
    Postal Code
    10977
    Country
    US
    Correspondent
    Shmelka Klein

    Products

    Device Name Product Code
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA

    Proprietary Names

    Kitlab RapidGo Flu A/B & Covid-19 Home Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198