BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Access CK-MB

    DI: 15099590781521 · Model: D00534 · Beckman Coulter, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Access CK-MB
    Primary DI
    15099590781521
    Version / Model
    D00534
    Catalog Number
    D00534
    Company Name
    Beckman Coulter, Inc.
    Labeler DUNS
    008254708
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-01
    Public Version
    1
    Public Version Date
    2024-03-11
    Public Version Status
    New
    Public Device Record Key
    81e0a3f8-6958-4d8f-bc43-919d96b9d4f8

    Device Description

    The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    JHX Fluorometric Method, Cpk Or Isoenzymes

    GMDN Terms

    Code Name
    52996 Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent

    Identifiers

    Type ID
    Primary 15099590781521