MTB-RIF/INH test is used to detect antibiotic resistance mutations in the Mycobacterium tuberculosis
Roche secured the CE-IVD mark for its Cobas MTB-RIF/INH test, an assay used to detect antibiotic resistance mutations in the Mycobacterium tuberculosis DNA. The assay runs on the company’s Cobas 6800/8800 automated molecular platforms and is part of its mycobacteria test menu. The highly-sensitive test helps clinicians in speeding up the diagnosis and treatment of TB by detecting antimicrobial resistance. This assay is part of the mycobacteria test menu that includes the cobas MTB and cobas MAI tests for use on the cobas 6800/8800 Systems.
CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and the device may be legally commercialized in the EU.
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