Viral infectious disease IVDs

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Cepheid Holdings Pty Ltd

Clasă:

Class 2

Produs de:

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

Zonă Terapeutică:

CT355 - Viral infectious disease IVDs

Indicații terapeutice:

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.

Statutul autorizaţiei:

A

Data de autorizare:

2014-04-30