BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    OpsisDx

    DI: B550ENT0040 · Model: Standard Media · ENTOPSIS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    OpsisDx
    Primary DI
    B550ENT0040
    Version / Model
    Standard Media
    Catalog Number
    ENT004
    Company Name
    ENTOPSIS, LLC
    Labeler DUNS
    078294784
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-08-26
    Public Version
    2
    Public Version Date
    2024-04-12
    Public Version Status
    Update
    Public Device Record Key
    9d814bb1-9d9a-42db-8505-bb8d5419d210
    Distribution End Date
    2023-01-01

    Device Description

    Media used for quality control of the OpsisDx platform

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NSU Instrumentation For Clinical Multiplex Test Systems

    GMDN Terms

    Code Name
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Primary B550ENT0040