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City Nucleic Acid / Rockville / Washington / / Company Tambrands Inc. / Medtronic Inc. / / Country United States / / Currency USD / / Facility Disease Control (CDC)/National Institute of Allergy / / / IndustryTerm product development protocol / lower risk devices / healthcare workers handling specimens / predicate device / nucleic acid-based in vitro diagnostic devices / Web site addresses / classified postamendment devices / healthcare workers / nucleic acid-based systems / acid-based in vitro diagnostic devices / diagnostic devices / postamendment devices / postamendment device / legally-marketed predicate device / / MedicalCondition M. tuberculosis / tuberculosis infection / acid-fast smear negative tuberculosis / disease / pulmonary tuberculosis / Mycobacterium tuberculosis / suspected tuberculosis / active tuberculosis / active pulmonary tuberculosis / infection / tuberculosis / / Organization Institute of Allergy and Infectious Diseases / office of Management and Budget / DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration / Congress / Medical Devices Advisory Committee / Center for Devices and Radiological Health / Division of Dockets Management / FDA / / Person Silver Spring / Leslie Kux / / / Position Governor / Commissioner / Executive / Acting Assistant Commissioner for Policy / / ProvinceOrState Maryland / / PublishedMedium Morbidity and Mortality Weekly Report / / Technology Diagnostic Tests / product development protocol / pdf / http / / URL http / SocialTag 
[removed]Federal Register / Vol. 77, No[removed]Monday, March 19, [removed]Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES