BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Status iFOBTest Control Kit

    DI: 10743816001102 · Model: BSP-300-C-01 · PRINCETON BIOMEDITECH CORPORATION
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Status iFOBTest Control Kit
    Primary DI
    10743816001102
    Version / Model
    BSP-300-C-01
    Catalog Number
    BSP-300-C-01
    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
    3
    Public Version Date
    2020-04-06
    Public Version Status
    Update
    Public Device Record Key
    2435f71a-1469-4536-b792-ec2d2320acfd

    Device Description

    Status iFOBTest Control Kit (1 Pos/1 Neg)

    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
    Yes
    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

    GMDN Terms

    Code Name
    38218 Faecal occult blood IVD, control

    Identifiers

    Type ID
    Primary 10743816001102

    Customer Contacts

    Phone
    8005262125
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius