Multiplex PCR Assay for cobas 4800 system uses self-collected male urine and vaginal swab samples. FDA granted 510(k) clearance for Roche’s cobas® CT/NG Test for detecting Chlamydia trachomatis (CT) ...
Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments ...