BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioPlex 2200

    DI: 00847865001366 · Model: SW4.1V1 · 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
    00847865001366
    Version / Model
    SW4.1V1
    Catalog Number
    6653265E
    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
    2020-01-23
    Public Version Status
    Update
    Public Device Record Key
    be9e0f33-1832-4e83-b742-86c7e95226bc

    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
    NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
    JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
    JJY Multi-analyte controls, all kinds (assayed)

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00847865001366

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 1 Each