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. Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022 Subject(s): Diagnostic Test ApprovalGovernment RegulationReagent Kits, DiagnosticUnited StatesUnited States. Food and Drug Administration
