BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BinaxNOW™ COVID-19/Flu A&B

    Reg #: 3004146366 · FEI: 3004146366 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSANG Healthcare CO., LTD.
    Registration Number
    3004146366
    FEI Number
    3004146366
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    132, Anyangcheondong-ro, DONGAN-GU
    City
    ANYANG Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K243262

    Owner / Operator

    Firm Name
    OSANG HEALTHCARE CO., LTD.
    Operator Number
    9056376
    Address
    132, Anyangcheondong-ro, Dongan-gu
    City
    Anyang
    State
    Gyeonggi
    Postal Code
    14040
    Country
    KR
    Correspondent
    Chulhun Kang

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

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

    Proprietary Names

    BinaxNOW™ COVID-19/Flu A&B QuickFinder™ COVID-19/Flu Antigen Self Test BinaxNOW™ COVID-19/Flu A&B Combo Self Test QuickFinder™ COVID-19/Flu Antigen Pro Test

    Establishment Types

    Manufacture Medical Device