Home » Roche OK’d for Chlamydia and Gonorrhea Detection Tests
Roche OK’d for Chlamydia and Gonorrhea Detection Tests
Devices Submissions and Approvals
The FDA granted Roche 510(k) clearance for its cobas CT/NG assay for Chlamydia trachomatis and Neisseria gonorrhea for its 6800/8800 systems.
The tests identify the DNA of the sexually transmitted pathogens, so patients can be either symptomatic or asymptomatic.
The assays can be used on urinary samples, vaginal swabs, or endocervical and cervical swab specimens.