BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CareStart COVID-19 Antigen Home Test

    Reg #: 3017193802 · FEI: 3017193802 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Access Bio. Inc
    Registration Number
    3017193802
    FEI Number
    3017193802
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    75 SSangnimgongdan-gil
    City
    Ssangnim-myeon, Goryeong-gun Gyeongbuk
    Country
    KR

    Owner / Operator

    Firm Name
    ACCESS BIO INCORPORATE
    Operator Number
    10028116
    Address
    65 Clyde Rd. Suite A
    City
    Somerset
    State
    NJ
    Postal Code
    08873
    Country
    US

    US Agent

    Business Name
    ACCESS BIO INCORPORATE
    Contact Name
    Sung Jang
    Address
    65 Clyde Road, Suite A
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US
    Email
    [email protected]
    Phone
    732 8734040 ext. 360

    Products

    Device Name Product Code
    Coronavirus Antigen Detection Test System. QKP

    Proprietary Names

    CareStart COVID-19 Antigen Home Test CareStart COVID-19 Antigen on/go COVID-19 Antigen SelfTest

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)