Cepheid Xpert MTBRIF Ultra

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

제공처:

SPD SCIENTIFIC PTE LTD

수업:

Class C IVD

Manufactured by:

Cepheid AB

치료 영역:

Microbiology

치료 징후:

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.

제품 요약:

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

승인 날짜:

2018-05-31