BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Extraction Kit - 12 buffer containers

    DI: EBUHBCALEX120 · Model: B-CAL-EX12 · Bühlmann Laboratories AG
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Extraction Kit - 12 buffer containers
    Primary DI
    EBUHBCALEX120
    Version / Model
    B-CAL-EX12
    Company Name
    Bühlmann Laboratories AG
    Labeler DUNS
    481261006
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-15
    Public Version
    2
    Public Version Date
    2020-11-06
    Public Version Status
    Update
    Public Device Record Key
    c195ba26-6740-4257-9370-211b2cc0751a

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    Yes
    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
    62669 Clinical specimen extraction buffer IVD

    Identifiers

    Type ID
    Primary EBUHBCALEX120

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius