BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HER-2 neu MMab

    DI: B502BSB56340 · Model: Concentrate, 0.1 ml · BIO SB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HER-2 neu MMab
    Primary DI
    B502BSB56340
    Version / Model
    Concentrate, 0.1 ml
    Catalog Number
    BSB 5634
    Company Name
    BIO SB, INC.
    Labeler DUNS
    102855447
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-16
    Public Version
    3
    Public Version Date
    2025-03-04
    Public Version Status
    Update
    Public Device Record Key
    45f4e058-0faf-4fe3-a6fa-97fa10a48b47

    Device Description

    HER2/neu is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MVU Reagents, Specific, Analyte

    GMDN Terms

    Code Name
    57047 Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

    Identifiers

    Type ID
    Primary B502BSB56340