BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioPlex 2200

    DI: 03610520563922 · Model: 4.3_v5 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioPlex 2200
    Primary DI
    03610520563922
    Version / Model
    4.3_v5
    Catalog Number
    12001443
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    884513334
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-02-29
    Public Version
    3
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    5ba14221-437e-46e0-b3f6-2723de1773c2

    Device Description

    U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443

    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
    No
    PM Exempt
    No
    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
    MZF Test, Hiv Detection

    GMDN Terms

    Code Name
    43472 Laboratory instrument/analyser application software IVD

    Identifiers

    Type ID
    Primary 03610520563922

    Customer Contacts

    Phone
    +1(800)224-6723
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 1 Each