BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareStartTM EZ COVID-19 IgM/IgG

    Reg #: 3003966368 · FEI: 3008474767 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ACCESS BIO INCORPORATE
    Registration Number
    3003966368
    FEI Number
    3008474767
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    65 Clyde Rd Ste A
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US

    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

    Products

    Device Name Product Code
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    CareStartTM EZ COVID-19 IgM/IgG Rapid ResponseTM Liberty COVID-19 IgG/IgM CareStart COVID-19 Antibody External Controls CareStartTM COVID-19 IgM/IgG

    Establishment Types

    Manufacture Medical Device