Mycobacteria IVDs - Mycobacteria IVDs

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Verfügbar ab:

Cepheid Holdings Pty Ltd

Klasse:

Class 3

Hergestellt von:

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

Therapiebereich:

CT791 - Mycobacteria IVDs

Anwendungsgebiete:

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)

Berechtigungsstatus:

A

Berechtigungsdatum:

2013-04-04