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# Roche Gains cobas TV/MG Test Clearance
- URL: https://www.fdaweb.com/roche-gains-cobas-tv-mg-test-clearance/
- Published: 2019-05-23T12:00:00.000Z
- Updated: 2026-09-15T01:28:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144176

FDA has cleared a Roche 510(k) for the cobas TV/MG test for use on the cobas 6800/8800 Systems for detecting *Trichomonas vaginalis* (TV) and *Mycoplasma genitalium* (MG) DNA in both symptomatic and asymptomatic patients. The expanded clearance now permits laboratories to simultaneously process from a single patient sample a combination of sexually transmitted infections, including *Chlamydia trachomatis*, *Neisseria gonorrhoeae*, *Trichomonas vaginalis*, and *Mycoplasma genitalium*, Roche says. The cobas TV/MG test has been validated for use with broad specimen types, including male/female urine, endocervical swabs and vaginal swabs, it says.