BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System

    DI: B502BSB0350150 · Model: 15 ml each (150 tests) · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mouse/Rabbit ImmunoDetector AP, w/ALK Scarlet Detection System
    Primary DI
    B502BSB0350150
    Version / Model
    15 ml each (150 tests)
    Catalog Number
    BSB 0350-15
    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
    0987bc3d-25f1-4ec9-ae97-839ead639942

    Device Description

    The Mouse/Rabbit ImmunoDetector Alkaline Phosphatase/ ALK Scarlet Detection System is a Biotin-Streptavidin-Alkaline Phosphatase Detection System used for the demonstration of antigens in formalin-fixed paraffin-embedded tissue, 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
    57767 Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

    Identifiers

    Type ID
    Primary B502BSB0350150