BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioPlex 2200

    DI: 03610522053131 · Model: 12008626 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioPlex 2200
    Primary DI
    03610522053131
    Version / Model
    12008626
    Catalog Number
    12008626
    Company Name
    BIO-RAD LABORATORIES, INC.
    Labeler DUNS
    884513334
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-11-27
    Public Version
    1
    Public Version Date
    2019-12-05
    Public Version Status
    New
    Public Device Record Key
    79528d0c-e96e-481c-b724-8f0716a3084d

    Device Description

    U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1

    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
    JIX Calibrator, multi-analyte mixture
    JJY Multi-analyte controls, all kinds (assayed)
    NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

    GMDN Terms

    Code Name
    54897 Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

    Identifiers

    Type ID
    Primary 03610522053131

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 1 Each