1. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018 Subject(s): Electronic Health RecordsHealth Information InteroperabilityLogical Observation Identifiers Names and CodesReagent Kits, DiagnosticDevice ApprovalIn Vitro Techniques -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. 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.
