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    FDA UDI In Commercial Distribution 🇺🇸 United States

    CAPI 3 NEONAT Hb AF Control

    DI: 03607360047576 · Model: 4757 · SEBIA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CAPI 3 NEONAT Hb AF Control
    Primary DI
    03607360047576
    Version / Model
    4757
    Catalog Number
    4757
    Company Name
    SEBIA
    Labeler DUNS
    276801933
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-30
    Public Version
    1
    Public Version Date
    2024-05-08
    Public Version Status
    New
    Public Device Record Key
    bbb53622-d35a-42be-8c92-39345f632045

    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
    Yes
    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
    JCM Control, Hemoglobin, Abnormal

    GMDN Terms

    Code Name
    57272 Haemoglobin detection IVD, control

    Identifiers

    Type ID
    Primary 03607360047576

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius
    Type
    Special Storage Condition, Specify
    Special Conditions
    This Way Up_Fragile-Handle with care_Keep Dry