The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished)


Product Overview

The Verigene® Processor SP is an instrument which integrates sample preparation, target amplification, and target hybridization within a single device as part of the Verigene® System, a benchtop molecular diagnostics workstation that utilizes patented gold nanoparticle technology to detect nucleic acid targets of interest for a variety of applications. (Refurbished)
Verigene® Processor SP (Refurbished) - 10-0000-07R


Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative simultaneous determination of multiple chemical and/or biological markers in a single clinical specimen using an immunological method which incorporates multiple antibodies arranged on a solid surface (e.g., slide, plate, membrane) or coated to micro-particles. It typically includes a system for the detection of bound target antigen (e.g., chemiluminescent, fluorescent, photometric, magnetic detector), together with sample processing, data processing and data display software.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NSU

    Device Name: Instrumentation For Clinical Multiplex Test Systems

    Device Class: 2

    Physical State: N/A

    Definition: Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de

    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: 862.2570

    Third Party Flag: N

    Medical Specialty: CH


    Code: OOI

    Device Name: Real Time Nucleic Acid Amplification System

    Device Class: 2

    Physical State: Should not include microarray or electrophoresis detection methods or instruments.

    Definition: The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system.

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.2570

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00857573006409

    Device Type: Previous

    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


    Device Id: 00840487101490

    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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