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Polymerase chain reaction / Influenza / Laboratory techniques / Molecular biology / Animal virology / Orthomyxoviridae / Real-time polymerase chain reaction / Viral disease / TaqMan / Biology / Chemistry / Science


510(k) Summar Submitted By Centers for Disease Control and Prevention 1600 Clifton Road, NE Atlanta, GA 30333
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Document Date: 2013-06-10 14:13:24


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File Size: 524,65 KB

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City

Atlanta / Perth / /

Company

PCR Kit (with or without ROX) OR Quanta BioSciences / Qiagen Inc. / Quanta BioSciences / MagNA Pure LC / Enzyme Cornparison Quanta BioSciences / /

Country

United States / /

Event

Person Communication and Meetings / /

Facility

Stability Stable / /

IndustryTerm

clinical multiplex test systems / clinical site / /

MedicalCondition

predominant influenza A / influenza A/H3 / novel virulent influenza viruses / influenza-like illness / disease / human influenza viruses / novel influenza A / Organism Detected Universal influenza A / seasonal influenza / seasonal human influenza A / specific novel influenza A / influenza A/H5 / different influenza virus strains representing influenza B / CDC Human Influenza / influenza A / influenza virus infection / influenza H-Ia / Swineorigin influenza A / bacterial infection / influenza viruses / A/H lpdmO9 influenza virus / influenza virus / I influenza viruses / respiratory infection / If infection / MS / influenza / Influenza B / appropriate infection / /

Organization

U.S. Department of Health and Human Services / World Health Organization / National Park Service / TS / NA / Regulatory Affairs Office / FDA / National Center for Emerging / NW / CDC Influenza Division / Centers for Disease Control and Prevention / /

Person

Hye-Joo Kim / /

/

Position

Director / additional reporter / Associate Director / study director / technician / reporter / /

Product

BAL / Quanta qScriptTM / /

ProvinceOrState

Wisconsin / Anhui / Georgia / /

Technology

antibodies / Hybridization / /

SocialTag