The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program.


Product Overview

The illumigene C. difficile External Control Kit contains Positive and Negative Control Reagents for use with the illumigene C. difficile test kit. External controls are used as part of a routine quality control program.
illumigene C. difficile External Control Kit - 279920


Device Description

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid, including specific gene markers, from Clostridium difficile bacteria [e.g., genes conferring antimicrobial resistance (e.g., gyrA gene), virulence (e.g., ribotype 027), and genes encoding toxin A and/or B] in a clinical specimen and/or culture isolate.


Environmental Conditions

  • Handling 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: OMN

    Device Name: C. Difficile Nucleic Acid Amplification Test Assay

    Device Class: 1

    Physical State: kIt containing DNA positive control, DNA internal control, buffer containing deoxyribonucleic acids and magnesium chloride, DNA polymerase, DNA primers and DNA probes

    Definition: In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

    Submission Type ID: 4

    Review Panel: MI

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Nucleic acid amplification test

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Stool samples

    Regulation Number: 866.2660

    Third Party Flag: N

    Medical Specialty: MI


    Device Identifiers

    Device Id: 00840733101120

    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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