BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PolyDetector Alk Scarlet

    DI: B502BSB01420 · Model: 1000 ml · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PolyDetector Alk Scarlet
    Primary DI
    B502BSB01420
    Version / Model
    1000 ml
    Catalog Number
    BSB 0142
    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
    2
    Public Version Date
    2023-06-02
    Public Version Status
    Update
    Public Device Record Key
    537fa2be-5116-45e6-9fcb-9a92aeabd60c

    Device Description

    PolyDetector ALK Scarlet Substrate-Chromogen used in Alkaline Phosphatase Detection Systems for the 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

    Product Codes

    Code Name
    NJT Immunohistochemistry Reagents And Kits

    GMDN Terms

    Code Name
    58239 Chromogenic/colorimetric substrate reagent IVD

    Identifiers

    Type ID
    Primary B502BSB01420