BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CareStart Malaria pLDH (PAN)

    Reg #: 3003966368 · FEI: 3008474767 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    0

    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
    NED

    Proprietary Names

    CareStart Malaria pLDH (PAN) CareStart Malaria HRP2/pLDH (Pf/VOM) Combo CareStart Malaria pLDH (Pf) CareStart Malaria pLDH (Pf/PAN) CareStart Malaria Screen CareStart Malaria HRP2/pLDH (Pf/PAN) Combo CareStart Malaria/Pregnancy Combo (HRP2/pLDH/HCG) CareStart Malaria HRP2/pLDH (Pf/Pv) Combo CareStart Malaria HRP2/pLDH (Pf) CareStart Malaria HRP2 (Pf)

    Establishment Types

    Manufacture Device in the United States for Export Only