BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioPlex 2200

    DI: 03610520540633 · Model: SW Version 4.3 · 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
    03610520540633
    Version / Model
    SW Version 4.3
    Catalog Number
    12000958
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    884513334
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    4
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    7d354c79-5254-4b84-9024-e5fbf6f94629

    Device Description

    BioPlex 2200 System Operation Manual , Software Version 4.3

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NSU Instrumentation for clinical multiplex test systems

    GMDN Terms

    Code Name
    56705 Fluorescent immunoassay analyser IVD, laboratory

    Identifiers

    Type ID
    Primary 03610520540633

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    BK140112 000

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 1 EA