Viral infectious disease IVDs

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Compra

Commercializzato da:

Cepheid Holdings Pty Ltd

Classe:

Class 2

Prodotto da:

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

Area terapeutica:

CT355 - Viral infectious disease IVDs

Indicazioni terapeutiche:

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.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2014-04-30

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