BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioSign® iFOBTest

    DI: 10743816001041 · Model: BSP-300-25-00 · PRINCETON BIOMEDITECH CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioSign® iFOBTest
    Primary DI
    10743816001041
    Version / Model
    BSP-300-25-00
    Catalog Number
    BSP-300-25-00
    Company Name
    PRINCETON BIOMEDITECH CORPORATION
    Labeler DUNS
    362917692
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2022-06-10
    Public Version Status
    Update
    Public Device Record Key
    40e6106d-3c7b-4b64-9c75-7cf056fcd648

    Device Description

    BioSign® iFOBTest; 25 Test kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    KHE Reagent, Occult Blood

    GMDN Terms

    Code Name
    54532 Faecal occult blood IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 10743816001041

    Customer Contacts

    Phone
    7322741000
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius