BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Seracult Single Slide Fecal Occult Blood Test

    DI: 70818087012989 · Model: 37100200 · PROPPER MANUFACTURING COMPANY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1000

    Basic Information

    Brand Name
    Seracult Single Slide Fecal Occult Blood Test
    Primary DI
    70818087012989
    Version / Model
    37100200
    Company Name
    PROPPER MANUFACTURING COMPANY, INC.
    Labeler DUNS
    001483130
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1000
    Record Status
    Published
    Publish Date
    2019-03-07
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    aaa98620-265e-4174-b29a-c1e2facc3b74

    Device Description

    Seracult Single Slide Fecal Occult Blood Test

    Device Characteristics

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

    GMDN Terms

    Code Name
    54533 Faecal occult blood IVD, reagent

    Identifiers

    Type ID
    Primary 70818087012989
    Unit of Use 10818087012987

    Premarket Submissions

    Submission Number Supplement Number
    K834297 000