Product Overview

APTIMA - AC2, REFRIG, 250T, READY MADE


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 types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 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: LSL

    Device Name: Dna-Reagents, Neisseria

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: MI

    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: 866.3390

    Third Party Flag: N

    Medical Specialty: MI


    Code: QEP

    Device Name: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

    Device Class: 2

    Physical State: In vitro diagnostic device consisting of reagents and associated instrumentation for the detection of nucleic acid sequences from Mycoplasma genitalium in clinical specimens.

    Definition: A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.

    Submission Type ID: 1

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: In vitro diagnostic device that detects and identifies nucleic acid sequences from Mycoplasma genitalium in clinical specimens.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Clinical specimens from patients suspected of Mycoplasma genitalium infection.

    Regulation Number: 866.3393

    Third Party Flag: N

    Medical Specialty: MI


    Code: MKZ

    Device Name: Dna Probe, Nucleic Acid Amplification, Chlamydia

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: MI

    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: 866.3120

    Third Party Flag: Y

    Medical Specialty: MI


    Device Identifiers

    Device Id: 15420045514973

    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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