BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PolyDetector Liquid AEC HRP Red

    DI: B502BSB00110 · Model: Ready-To-Use 15 ml · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PolyDetector Liquid AEC HRP Red
    Primary DI
    B502BSB00110
    Version / Model
    Ready-To-Use 15 ml
    Catalog Number
    BSB 0011
    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
    c6a1c07e-39b7-47a7-957f-3bc4bfa4a353

    Device Description

    PolyDetector AEC HRP Red Ready-to-Use Substrate-Chromogen (3-Amino-9-ethylcarbazole) is a chromogen (color forming molecule) that develops into a red precipitate

    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
    NJT Immunohistochemistry Reagents And Kits

    GMDN Terms

    Code Name
    58239 Chromogenic/colorimetric substrate reagent IVD

    Identifiers

    Type ID
    Primary B502BSB00110