BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nano-Check TM AMI cTnI Cardiac Marker Test

    Reg #: 3005174594 · FEI: 3005174594 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NANO-DITECH CORPORATION
    Registration Number
    3005174594
    FEI Number
    3005174594
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    259 Prospect Plains Rd Bldg K
    City
    Cranbury
    State
    NJ
    ZIP
    08512
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102131

    Owner / Operator

    Firm Name
    NANO-DITECH CORPORATION
    Operator Number
    9071128
    Address
    259 Prospect Plains Rd, Bldg K
    City
    Cranbury
    State
    NJ
    Postal Code
    08512
    Country
    US
    Correspondent
    James B Chang

    Products

    Device Name Product Code
    Immunoassay Method, Troponin Subunit MMI

    Proprietary Names

    Nano-Check TM AMI cTnI Cardiac Marker Test

    Establishment Types

    Manufacture Medical Device