BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LAtrol NORMAL CONTROL PLASMA

    DI: 00850201006147 · Model: 816N · Biomedica ADI Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

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    Basic Information

    Brand Name
    LAtrol NORMAL CONTROL PLASMA
    Primary DI
    00850201006147
    Version / Model
    816N
    Catalog Number
    816N
    Company Name
    Biomedica ADI Inc.
    Labeler DUNS
    080600606
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    20562e22-e86b-4433-97a4-d72e176d1ddc

    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
    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
    GIZ PLASMA, CONTROL, NORMAL

    GMDN Terms

    Code Name
    46029 Lupus anticoagulant marker IVD, control

    Identifiers

    Type ID
    Primary 00850201006147
    Unit of Use 10850201006144