BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nano-CheckTM AMI 3 in 1

    DI: 00895160002137 · Model: CD302P · NANO-DITECH CORPORATION
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    20

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    Basic Information

    Brand Name
    Nano-CheckTM AMI 3 in 1
    Primary DI
    00895160002137
    Version / Model
    CD302P
    Catalog Number
    CD302P
    Company Name
    NANO-DITECH CORPORATION
    Labeler DUNS
    126544316
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    20
    Record Status
    Published
    Publish Date
    2016-09-14
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    e83bc498-c923-4515-b755-efd476676ad0

    Device Description

    In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JHT Chromatographic Separation, Cpk Isoenzymes
    DDR Myoglobin, Antigen, Antiserum, Control
    MMI Immunoassay Method, Troponin Subunit

    GMDN Terms

    Code Name
    47399 Multiple cardiac marker IVD, reagent

    Identifiers

    Type ID
    Primary 00895160002137
    Unit of Use 10895160002134

    Customer Contacts

    Phone
    609-409-3300
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius