BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Biotestcell® Pool

    DI: 07611969952670 · Model: 816065100 · Bio-Rad Medical Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    0
    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
    Biotestcell® Pool
    Primary DI
    07611969952670
    Version / Model
    816065100
    Catalog Number
    816065100
    Company Name
    Bio-Rad Medical Diagnostics GmbH
    Labeler DUNS
    312576506
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-17
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    61c82ff6-8b6d-4b40-815e-ef964a07f00d

    Device Description

    Reagent Red Blood Cells; 3.0 - 3.4%; pooled cells for use in detection of unexpected antibodies with TANGO instruments; 10ml

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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

    GMDN Terms

    Code Name
    52690 Pooled antibody screening reagent red blood cell IVD, antigen

    Identifiers

    Type ID
    Primary 07611969952670

    Customer Contacts

    Phone
    800-224-6723
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius