BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HPV MultiDetector HRP/AP Detection System Kit

    DI: B502BSB035470 · Model: Ready-to-use, 70 tests each · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HPV MultiDetector HRP/AP Detection System Kit
    Primary DI
    B502BSB035470
    Version / Model
    Ready-to-use, 70 tests each
    Catalog Number
    BSB 0354-7
    Company Name
    BIO SB, INC.
    Labeler DUNS
    102855447
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-08-31
    Public Version
    1
    Public Version Date
    2020-09-08
    Public Version Status
    New
    Public Device Record Key
    143592a3-84c3-4ee7-bfe2-b8de3f64cdbd

    Device Description

    Ready-to-use, HPV MultiDetector HRP/AP Kit dual stain includes a cocktail of Ki67 and p16 antibodies to form a sensitive and specific test for significant cervical lesions or oral and oropharyngeal SCC.

    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 B502BSB035470