Viral infectious disease IVDs

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Cepheid Holdings Pty Ltd

Klasse:

Class 2

Produsert av:

Cepheid AB Rontgenvagen 5, Solna, SE-171 54 Sweden

Terapeutisk område:

CT355 - Viral infectious disease IVDs

Indikasjoner:

The Xpert Norovirus Assay, performed on the Cepheid GeneXpert? Instrument Systems, is a qualitative in vitro diagnostic test for the rapid identification and differentiation of norovirus genogroup I and genogroup II from raw or unpreserved unformed stool specimens collected from individuals with symptoms of acute gastroenteritis. The test utilizes automated real-time reverse transcriptase polymerase chain reaction (rRT-PCR) to detect norovirus RNA. The Xpert Norovirus Assay is intended to aid in the diagnosis of norovirus infections.

Autorisasjon status:

A

Autorisasjon dato:

2014-04-30