BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    SPIFE Hemoglobin IEF Kit

    DI: M52534280 · Model: 3428 · HELENA LABORATORIES CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    SPIFE Hemoglobin IEF Kit
    Primary DI
    M52534280
    Version / Model
    3428
    Company Name
    HELENA LABORATORIES CORPORATION
    Labeler DUNS
    079396131
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-07
    Public Version
    3
    Public Version Date
    2019-11-28
    Public Version Status
    Update
    Public Device Record Key
    cfe7b3bb-320a-4ac6-a89e-5bce7fd1190e
    Distribution End Date
    2019-02-28

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    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
    JBD SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN

    GMDN Terms

    Code Name
    59807 Inherited haemoglobinopathy IVD, reagent

    Identifiers

    Type ID
    Primary M52534280

    Customer Contacts

    Phone
    +1(800)231-5663 ext. 1600
    Email
    [email protected]