1. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, April 1, 2019 Subject(s): BacillusEquipment SafetyReagent Kits, Diagnostic -- classificationReagent Kits, Diagnostic -- standardsBacteriophage Typing -- classificationEnzyme-Linked Immunosorbent Assay -- classificationFluorescent Antibody Technique -- classificationNucleic Acid Amplification Techniques -- classificationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
