Product Overview

EVOLIS - 89601

Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers, in a clinical specimen, using an immunological method which utilizes an enzyme-based detection system with sample processing, data processing and/or data display software. It uses enzyme-labelled antigens or antibodies and a solid-phase binding support (e.g., beads, microplates) to measure the substance of interest, typically antigens, antibodies, drugs, or endogenous substances in body fluids.

Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 80.00
    • 50.00
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • 5.00

  • Device Sizes

  • 1 each
    • 1 each

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: JJE

    Device Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.2160

    Third Party Flag: N

    Medical Specialty: CH

    Device Identifiers

    Device Id: 03610520013328

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

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