Simplexa™ Bordetella Direct


Product Overview

Simplexa™ Bordetella Direct
Simplexa™ Bordetella Direct - MOL2750


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 bacteria associated with upper and/or lower respiratory disease, which may include multiple genes conferring resistance to antimicrobial drugs, in a clinical specimen using a nucleic acid technique (NAT). Bacteria detected may include (but are not limited to) Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila psittaci, Chlamydia pneumonia, Coxiella burnetii, Legionella pneumophila and/or Bordetella pertussis.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • -10.00
    • -30.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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


    Device Identifiers

    Device Id: 20816101025620

    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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