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Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiver
Roche has received 510(k) clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas liat sexually transmitted ...
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Roche launches 'revolutionary' pathogen detection tech
The new test is compatible with Roche's cobas 5800, 6800, and 8800 molecular diagnostic analysers, which are widely used in hospitals and other clinical settings, without any need for upgrades.
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FDA clears Roche self-collection system for HPV screening
The kit is used at a clinic after the patient receives instructions from a healthcare worker, and the swab is then sent for laboratory testing using Roche’s cobas HPV test. It offers an ...