BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)

    DI: B103CSC30231 · Model: CSC3023 · International Point of Care Incorporated
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)
    Primary DI
    B103CSC30231
    Version / Model
    CSC3023
    Catalog Number
    CSC3023
    Company Name
    International Point of Care Incorporated
    Labeler DUNS
    243942278
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-12-07
    Public Version
    3
    Public Version Date
    2025-04-01
    Public Version Status
    Update
    Public Device Record Key
    92721a59-66c9-4c7a-8ac4-1df6ef051767
    Distribution End Date
    2025-04-01

    Device Description

    Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    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
    47016 Multiple cardiac marker IVD, control

    Identifiers

    Type ID
    Primary B103CSC30231
    Unit of Use B103CSC30230

    Customer Contacts

    Phone
    416-847-2777
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K981474 000