The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.


Product Overview

The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection.
Respiratory Pathogens Flex (RP Flex) Extraction Tray - 20-009-024


Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple viruses associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 2.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OOU

    Device Name: Parainfluenza Multiplex Nucleic Acid Assay

    Device Class: 2

    Physical State: Nucleic Acid Based Assay

    Definition: A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Multiplex nucleic acid assay

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: IVD

    Regulation Number: 866.3980

    Third Party Flag: N

    Medical Specialty: MI


    Code: OEM

    Device Name: Human Metapneumovirus (Hmpv) Rna Assay System

    Device Class: 2

    Physical State: Human metapneumovirus (hMPV) RNA detection assay systems are devices that consist of reagents and instruments for the detection of hMPV RNA extracted from human respiratory specimens or viral cultures.

    Definition: A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hMPV) RNA extracted from human respiratory specimens or viral cultures.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: in vitro diagnostic assay

    Regulation Number: 866.3980

    Third Party Flag: N

    Medical Specialty: MI


    Code: OZZ

    Device Name: Bordetella Pertussis Dna Assay System

    Device Class: 2

    Physical State: Bordetella pertussis DNA detection assay systems are devices that consist of reagents and instruments for the detection of Bordetella pertussis DNA extracted from human respiratory specimens.

    Definition: A qualitative in vitro diagnostic assay intended to detect Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to Bordetella pertussis DNA extracted from human respiratory specimens.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: in vitro diagnostic assay

    Regulation Number: 866.3980

    Third Party Flag: N

    Medical Specialty: MI


    Code: OCC

    Device Name: Respiratory Virus Panel Nucleic Acid Assay System

    Device Class: 2

    Physical State: A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures. Detection and differentiation of specific virus RNA or DNA aids in the diagnosis of respiratory infections in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of infection with these viruses.

    Definition: A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses: Influenza A and Influenza B, Influenza A subtype H1 and Influenza A subtype H3, Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus, Human Metapneumovirus, Rhinovirus, and Adenovirus.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: A qualitative in vitro diagnostic assay intended to simultaneously detect, identify, and/or differentiate multiple respiratory virus nucleic acid extracted from human respiratory specimens or viral cultures. Detection and differentiation of specific virus RNA or DNA aids in the diagnosis of respiratory infections in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of infection with these viruses.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: In vitro diagnostic device

    Regulation Number: 866.3980

    Third Party Flag: N

    Medical Specialty: MI


    Code: OZE

    Device Name: Influenza A And Influenza B Multiplex Nucleic Acid Assay

    Device Class: 2

    Physical State: Nucleic acid based assay

    Definition: An Influenza A and Influenza B multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of influenza A and influenza B nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of influenza A and B nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract influenza viral infections if used in conjunction with other clinical and laboratory findings.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Multiplex nucleic acid assay

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: IVD

    Regulation Number: 866.3980

    Third Party Flag: N

    Medical Specialty: MI


    Code: OEP

    Device Name: Influenza A Virus Subtype Differentiation Nucleic Acid Assay

    Device Class: 2

    Physical State: OIVD

    Definition: A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Direct nucleic acid detection

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Specific RNA segments

    Regulation Number: 866.3980

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00857573006263

    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: 00840487101667

    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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