Products/Xpert MTB/RIF Ultra

Xpert MTB/RIF Ultra

Cepheid (Danaher)
510(k) ClearedCE-IVD

Detection of MTB and rifampicin resistance from sputum, BAL, and other specimens

Technical Specifications

PlatformGeneXpert
MultiplexNo
Target Count2
Sensitivity≥90%
Specificity≥98%
Turnaround Time80 min
Storage Temperature2–28°C
Shelf Life18 months

Pathogen Targets (1)

Mycobacterium tuberculosis· bacteria

Sample Types

Bronchoalveolar lavage

Sputum

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K173245

510(k)

9/1/2017

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $10–$20

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.