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Roche announced today that the US Food and Drug Administration (FDA) has provided 510(k) clearance for cobas® CT/NG for use on the cobas® 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic individuals.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA clearance for the cobas® Factor II and Factor V Test for use on the cobas® 4800 system. The test enables laboratories to simultaneously assess Factor II and Factor V gene mutations from a single patient sample, which can reduce hands-on time when testing patients for inherited thrombophilia.
New test allows simultaneous processing of any combination of four separate sexually-transmitted infections (CT, NG, TV and MG) from one patient sample First and only high volume molecular test on market with approval for combination TV/MG testing using meatal …
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