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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 ...
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Roche nets clearances for sexually transmitted infection tests at the point of care
Roche has obtained U.S. government green lights allowing its point-of-care testing system to be used to screen for multiple ...
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Roche Launches Clinical Mass Spec System in Europe; Targets H2 2025 for Move Into US
Roche plans to release the system in the US to run tests including vitamin D and steroid assays under CLIA before it possibly receives US Food and Drug Administration clearance.