BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LuMatic CLIA Analyzer

    DI: 00816870020013 · Model: IN008 · MONOBIND, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LuMatic CLIA Analyzer
    Primary DI
    00816870020013
    Version / Model
    IN008
    Catalog Number
    IN008
    Company Name
    MONOBIND, INC.
    Labeler DUNS
    083155515
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-13
    Public Version
    1
    Public Version Date
    2024-09-23
    Public Version Status
    New
    Public Device Record Key
    b175a9e7-b57f-4aeb-b8cf-984d6e130b23

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJQ COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE

    GMDN Terms

    Code Name
    56701 Chemiluminescent immunoassay analyser IVD

    Identifiers

    Type ID
    Primary 00816870020013

    Customer Contacts

    Phone
    +1(949)951-2665
    Email
    [email protected]