1. Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 2, 2017 Subject(s): Clinical Laboratory TechniquesDevice Approval -- standardsDiagnostic Test Approval -- standardsIn Vitro Techniques -- standardsReagent Kits, Diagnostic -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
