Cepheid Xpert MTBRIF Ultra

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

SPD SCIENTIFIC PTE LTD

Class:

Class C IVD

Manufactured by:

Cepheid AB

Therapeutic area:

Microbiology

Therapeutic indications:

The Xpert MTB/RIF Ultra Assay, performed on the GeneXpert Instrument Systems, is a semi-quantitative, nested real-time polymerase chain reaction (PCR) in vitro diagnostic test for the detection of Mycobacterium tuberculosis (MTB) complex DNA in unprocessed sputum samples or concentrated sediments prepared from induced or expectorated sputum. In specimens where Mycobacterium tuberculosis complex is detected, the Xpert MTB/RIF Ultra Assay can also detect rifampin-resistance associated mutations of the rpoB gene. The Xpert MTB/RIF Ultra Assay is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no antituberculosis therapy, or less than 3 days of therapy in the last 6 months. This test is intended as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings.

Product summary:

Device System Info:[Device with measuring function], [System or Procedure Pack], ii) Device with Measuring Function iii) System or Procedure Pack; Models: Xpert MTB/RIF Ultra - GXMTB/RIF-ULTRA-10, Xpert MTB/RIF Ultra - GXMTB/RIF-ULTRA-50

Authorization date:

2018-05-31