Curetis Unyvero HPN Hospitalized Pneumonia Application

Land: Singapore

Taal: Engels

Bron: HSA (Health Sciences Authority)

Beschikbaar vanaf:

ACUMEN RESEARCH LABORATORIES PTE. LTD.

klasse:

Class C IVD

Geproduceerd door:

Curetis GmbH

Therapeutisch gebied:

Microbiology

therapeutische indicaties:

The Unyvero HPN Application is for use together with the Unyvero System. It is used to detect pneumonia-associated pathogens and the antibiotic resistance genes of these pathogens. Unyvero HPN Application is a DNA test based on the parallel execution of eight multiplex PCR reactions. It is for the simultaneous detection of multiple pathogen-associated nucleic acids in sputa, respiratory aspirates and bronchial lavages from patients with suspected pneumonia, with the aim to provide information on pathogen species and antibiotic resistance genes. The identification of specific non-viral pathogen DNA in patients with signs and symptoms of pneumonia helps in the diagnosis of respiratory infections caused by bacteria and/or fungi, if these results are used in conjunction with other clinical or laboratory methods. The Unyvero result should not be used alone for diagnosis and patient management.

Product samenvatting:

Device System Info:[Device with measuring function], [System or Procedure Pack], Fluorescence intensities from probe-hybridized PCR amplification products are measured to indicate the presence of microorganisms and/or antibiotics resistance genes. Unyvero instruments and the HPN application are always used together as an IVD SYSTEM.; Models: Unyvero HPN Hospitalized Pneumonia Cartridge Set - 10075, Unyvero HPN Hospitalized Pneumonia Cartridge - 10074, Unyvero T1 Sample Tube & Cap - 10066, Unyvero T1 Sample Tube & Cap Set - 10069, Unyvero T1 Sample Transfer Tool - 10005, Unyvero T1 Sample Transfer Tool Set - 10014, Unyvero M1 Master Mix Tube - 10002, Unyvero M1 Master Mix Tube Set - 10011, Unyvero A50 Analyzer - 60001, Unyvero L4 Lysator - 60002, Unyvero C8 Cockpit - 60003, Unyvero Sample Tube Holder - 60010

Autorisatie datum:

2018-02-06