Aptima® Trichomonas vaginalis Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther® System.


Product Overview

Aptima® Trichomonas vaginalis Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther® System.
Aptima® - KIT, ATV-V2, ROOM TEMP, 100T


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 the parasitic protozoan Trichomonas vaginalis in a clinical specimen, using a nucleic acid technique (NAT).


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 15.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OUY

    Device Name: Trichomonas Vaginalis Nucleic Acid Amplification Test System

    Device Class: 2

    Physical State: May include target capture, transcription-mediated amplification, semi automated analyzer

    Definition: In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Uses target capture, transcription-mediated amplification and hybridization protection assay technologies to stream line specimen processing, amplify target rRNA and detect amplicon respectively

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Vaginal, cervical,endocervical, urogenital and gynecological specimens

    Regulation Number: 866.3860

    Third Party Flag: N

    Medical Specialty: IM


    Device Identifiers

    Device Id: 15420045505520

    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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