Products/cobas MTB/RIF

cobas MTB/RIF

Roche Diagnostics
510(k) ClearedCE-IVD

Detection of Mycobacterium tuberculosis and rifampicin resistance from sputum

Technical Specifications

Platformcobas Liat
MultiplexNo
Target Count2
Sensitivity≥95%
Specificity≥98%
Turnaround Time1 hr
Storage Temperature2–25°C
Shelf Life18 months

Pathogen Targets (1)

Mycobacterium tuberculosis· bacteria

Sample Types

Sputum

Detection Methods

RT-PCR

Regulatory Status

FDA510(k) Cleared

K211234

510(k)

5/10/2021

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $20–$40

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.