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City Nucleic Acid / Rockville / Washington / / Country United States / / Currency USD / / / Facility Disease Control (CDC)/National Institute of Allergy / / / IndustryTerm product development protocol / nucleic acid-based in vitro diagnostic device / predicate device / nucleic acid-based in vitro diagnostic devices / marketed predicate device / search capability / Web site addresses / marketed device / nucleic acid-based systems / acid-based in vitro diagnostic devices / diagnostic devices / postamendment devices / postamendment device / / MedicalCondition M. tuberculosis / tuberculosis infection / acid-fast smear negative tuberculosis / disease / pulmonary tuberculosis / Mycobacterium tuberculosis / suspected tuberculosis / active tuberculosis / Acute Coronary Syndrome / Heart Failure / active pulmonary tuberculosis / infection / tuberculosis / / Organization Specific Intended Uses AGENCY / Institute of Allergy and Infectious Diseases / Federal Trade Commission / office of Management and Budget / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Medical Devices Advisory Committee / Center for Devices and Radiological Health / Division of Dockets Management / FDA / Respiratory Specimens AGENCY / / Person Silver Spring / Donald S. Clark / Leslie Kux / / Position Assistant Commissioner for Policy / Secretary / Governor / Commissioner / Executive / / ProgrammingLanguage C / / ProvinceOrState Maryland / / PublishedMedium Public Law / Morbidity and Mortality Weekly Report / / Technology Diagnostic Tests / product development protocol / pdf / http / / URL www.fda.gov/downloads/ScienceResearch / http / SocialTag 
[removed]Federal Register / Vol. 78, No[removed]Wednesday, June 19, [removed]Proposed Rules E. Duplicative, Overlapping, or Conflicting Federal Rules