BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    POINTE SCIENTIFIC CK-MB Controls

    DI: 00811727010971 · Model: C7562-12 · HORIBA INSTRUMENTS INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    POINTE SCIENTIFIC CK-MB Controls
    Primary DI
    00811727010971
    Version / Model
    C7562-12
    Catalog Number
    C7562-12
    Company Name
    HORIBA INSTRUMENTS INCORPORATED
    Labeler DUNS
    052845583
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-31
    Public Version
    4
    Public Version Date
    2025-10-02
    Public Version Status
    Update
    Public Device Record Key
    3e92c450-0a4e-440d-ac17-a1d15b330b5b

    Device Description

    This CK-MB Isoenzyme Control has been assayed for CK-MB and is intended to be used as a human serum control product for CK-MB determinations.

    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    44693 Creatine kinase myocardial isoenzyme (CKMB) IVD, control

    Identifiers

    Type ID
    Primary 00811727010971

    Customer Contacts

    Phone
    800-445-9853
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K954074 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius