BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CD117 c-Kit PolyDetector DAB HRP Brown

    DI: B502BSB02550 · Model: 150 tests · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CD117 c-Kit PolyDetector DAB HRP Brown
    Primary DI
    B502BSB02550
    Version / Model
    150 tests
    Catalog Number
    BSB 0255
    Company Name
    BIO SB, INC.
    Labeler DUNS
    102855447
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-30
    Public Version
    1
    Public Version Date
    2020-10-08
    Public Version Status
    New
    Public Device Record Key
    da293315-f10e-44d4-b5ea-7a0dd394c869

    Device Description

    CD117/c-kit PolyDetector DAB HRP Brown Detection System is a non-biotin, 1-step polymeric detection system that allows for the Immunohistochemical detection of CD117 expression in normal and neoplastic formalin-fixed paraffin-embedded tissues.

    Device Characteristics

    Single Use
    No
    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
    MR Safe
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NJT Immunohistochemistry Reagents And Kits

    GMDN Terms

    Code Name
    57771 Immunohistochemistry chromogenic substrate IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary B502BSB02550