TessArae LLC / BioCryst / RAC Director United States / Chemical Biological Medical Systems / Cepheid / Notices 20447 Q. Only Focus Diagnostics / D. Focus Diagnostics / DxNA LLC / N. CLIA High Complexity Laboratories / CLIA High Complexity Laboratories / Prodesse Inc. / Qualified DoD Laboratories / Roche Diagnostics GmbH / H. Focus Diagnostics / L. CLIA High Complexity Laboratories / DoD Laboratories / Army incorporated / Diatherix Laboratories Inc. / Focus Diagnostics A. Focus Diagnostics / CLIA High Complexity Laboratories P. Focus Diagnostics / Focus Diagnostics Inc. / Epoch BioSciences / O. CLIA High Complexity Laboratories / High Complexity Laboratories / R. Focus Diagnostics / K. Focus Diagnostics / I. Focus Diagnostics / ELITech Molecular Diagnostics / RUO / C. Focus Diagnostics / M. CLIA High Complexity Laboratories / University Pathologists Laboratories / B. Focus Diagnostics / Qiagen / M.D. / D. / M.D. Principal Deputy / /
Country
United States / /
Facility
JBAIDS Training Facility / /
IndustryTerm
certain in vitro diagnostic devices / manufacturing practice requirements / biological product / real-time polymerase chain reaction / system software / federal law / information relating / diagnostic devices / investigational devices / unapproved medical product / manufacturing / healthcare providers / /
MedicalCondition
specified disease / such disease / above described Flu A H1N1 / Swine Influenza A / Flu A H1N1 / H1N1 influenza virus infection / such a disease / universal influenza A / authorized Flu A H1N1 / Æ such disease / H1N1 influenza virus / FLU A / influenza / H1N1 Influenza A / H1N1 influenza / severe allergic reaction / human influenza A / disease / both human influenza A / Influenza A H1N1 / Influenza A / H1N1 flu / renal insufficiency / Swine influenza / diseases / respiratory infection / /
MedicalTreatment
antiviral therapy / /
Organization
U.S. Department of Health and Human Services / office of the Surgeon General / National Institute of Health / Food and Drug Administration / Availability AGENCY / Army / Centers for Disease Control and Prevention / National Park Service / United States Army / FDA / FDA PO / DEPARTMENT OF HEALTH AND HUMAN SERVICES Authorization of Emergency Use of Certain In Vitro Diagnostic Devices / Department of Defense / office of Counterterrorism and Emerging Threats / Joint Project Management Office / /
Person
Boris Lushniak / Joshua M. Sharfstein / John G. R. Hurrell / Charles E. Johnson / Leslie Kux / Robert E. Miller / Dennis L. Grimaud / Margaret A. Hamburg / /
Position
Chairman and Chief Executive Officer / Vice President and General Manager / Secretary of Defense / Secretary / Governor / Acting Secretary / Commissioner / Acting Assistant Commissioner for Policy / Ph. Vice President and General Manager / RAC Director / /
Product
BAL / rRT / Flu / /
ProvinceOrState
Alabama / Maryland / California / /
PublishedMedium
Public Law / /
Technology
laptop computer / in vitro diagnostics / drug delivery / DNA Chip / http / /
Federal Register / Vol. 75, No[removed]Monday, April 19, [removed]Notices b[removed]