BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    VIDAS® CK-MB

    DI: 03573026161613 · Model: 30421-01 · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VIDAS® CK-MB
    Primary DI
    03573026161613
    Version / Model
    30421-01
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    4
    Public Version Date
    2020-05-14
    Public Version Status
    Update
    Public Device Record Key
    3f0217f8-2f04-4a44-9af7-579fd2eca177
    Distribution End Date
    2018-01-01

    Device Description

    The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma.

    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
    No
    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
    47385 Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 03573026161613

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius