BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Lymphoscreen ABC-60

    DI: 07611969952939 · Model: 823300 · Bio-Rad Medical Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Let the assistant research this device

    The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Brand Name
    Lymphoscreen ABC-60
    Primary DI
    07611969952939
    Version / Model
    823300
    Catalog Number
    823300
    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
    2015-07-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    8399256a-671a-4b2a-b481-fbcb4476b9ce
    Distribution End Date
    2018-03-08

    Device Description

    Human lymphocytes for 6 detections of human HLA-ABC 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
    56537 HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)

    Identifiers

    Type ID
    Primary 07611969952939

    Customer Contacts

    Phone
    800-224-6723
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    BK980033 0

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    – -70 Degrees Celsius