BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ImmunoDetector Biotin Blocker

    DI: B502BSB00990 · Model: 50 ml · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ImmunoDetector Biotin Blocker
    Primary DI
    B502BSB00990
    Version / Model
    50 ml
    Catalog Number
    BSB 0099
    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
    4aa22b8e-9a97-4563-9664-7e67bd887511

    Device Description

    Two-step endogenous biotin blocking system used for immunohistochemistry (IHC) and in-situ hybridization (ISH) procedures to block endogenous biotin in frozen and formalin-fixed paraffin-embedded tissues (pancreas, kidney, liver, etc.) that contain higher levels of biotin and may yield false positive results.

    Device Characteristics

    Single Use
    No
    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
    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
    PPM General Purpose Reagent

    GMDN Terms

    Code Name
    57767 Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary B502BSB00990