BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PolyDetector HRP Black kit

    DI: B502BSB00890 · Model: 1000 Tests · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PolyDetector HRP Black kit
    Primary DI
    B502BSB00890
    Version / Model
    1000 Tests
    Catalog Number
    BSB 0089
    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
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    626df1e0-0cc2-4421-8bb1-0baf723c94d2

    Device Description

    PolyDetector HRP Black Substrate-Chromogen used with peroxidase detection systems for demonstration of cell antigens or nucleic acids in paraffin embedded tissues, cryostat sections, cytosmears, and cell preparations

    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

    GMDN Terms

    Code Name
    58239 Chromogenic/colorimetric substrate reagent IVD

    Identifiers

    Type ID
    Primary B502BSB00890