BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BioPlex 2200

    DI: 00847865004725 · Model: SW4_V2 · BIO-RAD LABORATORIES, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BioPlex 2200
    Primary DI
    00847865004725
    Version / Model
    SW4_V2
    Catalog Number
    6653360E
    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
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2205f671-2a89-496f-9d10-68a1707d428e

    Device Description

    Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2

    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
    MXJ Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1
    MYF Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2

    GMDN Terms

    Code Name
    49544 Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

    Identifiers

    Type ID
    Primary 00847865004725

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 1 Each