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NEW YORK (GenomeWeb) – Roche said today that the US Food and Drug Administration has provided 510(k) clearance for its Cobas CT/NG assay for use on its Cobas 6800 and 8800 systems. The assay and systems have been cleared to directly detect the DNA of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in symptomatic and asymptomatic individuals.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.