Roche's Cobas TV/MG Test Receives FDA's 510 (k) Clearance for the Detection of Sexually Transmitted Diseases
Shots:
- Roche has received 510(k) clearance for its Cobas TV/MG test runs on Cobas 6800/8800 System to detect Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients
- The addition of Cobas TV/MG test expands the testing menu on the Cobas 6800/8800 Systems and has been validated to use with multiple specimens including male/female urine- endocervical swabs and vaginal swabs
- The combination of Cobas TV/MG with Cobas Chlamydia trachomatis (CT)/ Neisseria gonorrhoeae (NG) based on PCR technology- used for the detection of CT & NG- providing high throughput solutions supporting the molecular testing needs
Ref: Roche | Image: Roche
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