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Epsilometer test / Medical laboratory / Verification and validation / Technology / Medicine / Microbiology / Science


Guidelines for Laboratory Verification of Performance of the FilmArray® Respiratory Panel (RP) Purpose ADVISORY
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Document Date: 2015-03-30 10:13:12

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File Size: 774,75 KB

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City

Buffalo / /

Company

ADVISORY NOTICE BioFire Diagnostics LLC / ZeptoMetrix Corporation / FilmArray Respiratory Panel Kit (30 tests) BioFire DiagnosticsLLC / BioFire Diagnostics LLC / /

/

Event

FDA Phase / /

Facility

Laboratory Verification / /

IndustryTerm

verification protocol / Performance verification protocols / /

MedicalCondition

respiratory tract infections / Parainfluenza virus / Bordetella pertussis / Human Rhinovirus/Enterovirus Influenza A / Adenovirus Influenza A / Influenza A / Influenza B / /

Organization

FDA / National Park Service / /

/

Position

Laboratory Director / /

Product

FilmArray Respiratory Panel / M-16 / FLM1-PRT / ASY-0105 / HKU1 / /

Technology

verification protocol / following protocol / 0.6 mL An example VTM Protocol / Performance verification protocols / 14 Verification Protocol / process control / /

URL

www.BioFireDX.com / /

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