BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Triage

    DI: 30014613337959 · Model: 97300EU · QUIDEL CARDIOVASCULAR INC.
    View on AccessGUDID
    Product Codes
    5
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Triage
    Primary DI
    30014613337959
    Version / Model
    97300EU
    Catalog Number
    97300EU
    Company Name
    QUIDEL CARDIOVASCULAR INC.
    Labeler DUNS
    080890141
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-01
    Public Version
    2
    Public Version Date
    2020-04-02
    Public Version Status
    Update
    Public Device Record Key
    52ac0044-5d56-4532-a782-ee0a6cf95c63

    Device Description

    Triage Profiler SOB Panel (OUS)

    Device Characteristics

    Single Use
    Yes
    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
    DDR MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
    MMI IMMUNOASSAY METHOD, TROPONIN SUBUNIT
    JHX FLUOROMETRIC METHOD, CPK OR ISOENZYMES
    NBC TEST,NATRIURETIC PEPTIDE
    DAP FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    47384 Multiple cardiac marker IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 30014613337959

    Customer Contacts

    Phone
    +1(858)552-1129
    Email
    [email protected]