Mycobacteria IVDs - Mycobacteria IVDs

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Cepheid Holdings Pty Ltd

Classe:

Class 3

Prodotto da:

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

Area terapeutica:

CT791 - Mycobacteria IVDs

Indicazioni terapeutiche:

The Xpert MTB/RIF Assay for use with the Cepheid GeneXpert system is a semi-quantitative, nested real-time PCR in-vitro diagnostic test for the detection of: ? Mycobacterium tuberculosis complex DNA in sputum samples or concentrated sediments prepared from induced or expectorated sputa that are either acid-fast bacilli (AFB) smear positive or negative ? Rifampin-resistance associated mutations of the rpoB gene in samples from patients at risk for rifampin resistance The Xpert MTB/RIF Assay is intended for use with specimens from untreated patients for whom there is clinical suspicion of tuberculosis (TB)

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2013-04-04