This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on average, the ...
Roche's Ionify® steroid assays join its Vitamin D Total test as the latest mass spectrometry tests to receive CLIA 'moderate complexity' classification. The expanded steroid menu brings the ...
First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. Expands access to advanced testing with a fully automated, ...
The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part ...
The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...
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