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Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

First mass spectrometry-based test system for total 25-Hydroxyvitamin D to receive CLIA 'Moderate Complexity' designation in the U.S. "Achieving this level of automation for a mass spectrometry assay ...
Hosted on MSN

Roche achieves CLIA ‘Moderate Complexity’ categorization for Ionify assay

Roche (RHHBY) announced that the U.S. Food and Drug Administration has categorized its Ionify 25-Hydroxy Vitamin D total assay as “Moderate Complexity” under the Clinical Laboratory Improvement ...
News Medical

Focus Diagnostics announces FDA clearance for Simplexa Group A Strep Direct Kit

Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics (NYSE: DGX), today announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa ...
Morningstar

Roche achieves first CLIA 'Moderate Complexity' categorization for Ionify® 25-Hydroxy Vitamin D total test

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, ...