BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Envoy

    DI: 08033622964544 · Model: Envoy 500+ · BIOTECNICA INSTRUMENTS SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Envoy
    Primary DI
    08033622964544
    Version / Model
    Envoy 500+
    Catalog Number
    03-07050-01
    Company Name
    BIOTECNICA INSTRUMENTS SPA
    Labeler DUNS
    436575930
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-18
    Public Version
    1
    Public Version Date
    2020-09-28
    Public Version Status
    New
    Public Device Record Key
    a42f59dd-ddea-488d-b018-e97a895fe241

    Device Description

    Multiple clinical chemistry analyser IVD, laboratory, semi-automated: An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

    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
    Yes
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    GMDN Terms

    Code Name
    56679 Multiple clinical chemistry analyser IVD, laboratory, semi-automated

    Identifiers

    Type ID
    Primary 08033622964544