BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Genemed®

    DI: 00615233011183 · Model: 61-0185 · SAKURA FINETEK U.S.A., INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Genemed®
    Primary DI
    00615233011183
    Version / Model
    61-0185
    Catalog Number
    61-0185
    Company Name
    SAKURA FINETEK U.S.A., INC.
    Labeler DUNS
    179135769
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-16
    Public Version
    1
    Public Version Date
    2023-10-24
    Public Version Status
    New
    Public Device Record Key
    b73adc30-2d4a-4dc3-8edd-f11f6ecc0d6f

    Device Description

    anti-PRAME Rabbit Monoclonal Antibody [QR005], Concentrate, 1 mL

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    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
    65250 Preferentially expressed antigen in melanoma (PRAME) IVD, antibody

    Identifiers

    Type ID
    Primary 00615233011183