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CLIA Currently Waived Analytes

Published by U.S. Food and Drug Administration | U.S. Department of Health & Human Services | Metadata Last Checked: August 09, 2025 | Last Modified: 2013-11-01
This database contains the commercially marketed in vitro test systems categorized as CLIA waived by the FDA since January 31, 2000, and by the Centers for Disease Control and Prevention (CDC) prior to that date. CLIA waived test systems are waived from certain CLIA laboratory requirements (42 CFR Part 493).

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