BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Lymphoscreen DR 30x2

    DI: 07611969965717 · Model: 823350 · Bio-Rad Medical Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Lymphoscreen DR 30x2
    Primary DI
    07611969965717
    Version / Model
    823350
    Company Name
    Bio-Rad Medical Diagnostics GmbH
    Labeler DUNS
    312576506
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-08
    Public Version
    3
    Public Version Date
    2024-01-19
    Public Version Status
    Update
    Public Device Record Key
    0b411353-c4cb-4a41-b83b-11cd141a3999
    Distribution End Date
    2023-12-31

    Device Description

    Human lymphocytes for 12 detections of human HLA-DR/DQ antibodies in the complement-dependent microlymphocytotoxicity test

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MZI Test,Qualitative,For Hla,Non-Diagnostic

    GMDN Terms

    Code Name
    56551 HLA class II antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)

    Identifiers

    Type ID
    Primary 07611969965717

    Customer Contacts

    Phone
    800-224-6723
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -70 Degrees Celsius