WebFilmArray Global Fever Panel External Control Kit: Applicant: BioFire Defense, LLC: 79 West 4500 South, Suite 14: Salt Lake City, UT 84107 Applicant Contact: Cynthia Phillips: Correspondent: BioFire Defense, LLC: 79 West 4500 South, Suite 14: Salt Lake City, UT 84107 Correspondent Contact: Cynthia Phillips: Regulation Number: 866.3920: ... WebThe BioFire Global Fever Special Pathogens Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplexed polymerase chain reaction …
Device Classification Under Section 513(f)(2)(De Novo)
WebFilmArray® Global Fever Panel - RUO • Fully Automated: Sample prep, amplification, identification, and reporting. • Single Instrument Integration: Minimal equipment and consumables. • Freeze-dried Reagents: Room temperature stable. The RUO FilmArray Global Fever Panel tests for a comprehensive list of 9 viral, 6 bacterial and 4 protozoan WebAug 16, 2024 · The Global Fever Panel is an in vitro diagnostic used to analyze specimens of human blood in conjunction with the BioFire FilmArray, an instrument found in many DOD “brick and mortar” hospital ... list of pubs in suffolk
Juliana Mourão, PhD บน LinkedIn: #eccmid2024 …
WebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed nucleic acid-based test designed to be used with BioFire ®®FilmArray Systems (BioFire FilmArray® 2.0 or BioFire® FilmArray® Torch). The BioFire Global Fever … WebWe aimed to evaluate the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood specimens run on the BioFire FilmArray System, in the diagnosis of several pathogens that cause acute febrile illness. Methods: We did a prospective, multicentre, cross-sectional diagnostic ... WebMake lunch hour count at #ECCMID2024! 📅 On April 16, join us for our Integrated Symposium: The value of diagnostic information for #antimicrobialstewardship… imiona lalek rainbow high