The Key to Reopening Economies
Systematic lab testing and comprehensive dashboards support better decisionmaking.
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Search Results for: compliance
FDA Updates Templates for Serology Test EUA Requests
The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
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Clinical Chemistry Reference Kit
The set of definitive method reference materials contains seven routine chemistry components, covering 42 individual concentrations.
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Managing Prior Authorizations with Artificial Intelligence
AI-driven software can help labs expertly navigate the prior authorization landscape.
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FDA Proposes to Reclassify Two Types of Hepatitis C Virus Diagnostic Tests
If the agency’s proposed reclassification is finalized, devices of this type may go through the 510(k) pathway for clearance instead of the premarket approval (PMA) pathway.
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