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 … WebJan 8, 2024 · The FilmArray®Global Fever Panel is a commercially available single-use, fully enclosed test for use with the BioFire®FilmArray 2.0 instrument to aid in the …
BioFire COVID-19 Testing Solutions BioFire Diagnostics
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: ... 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 ... how many pounds is a 4 month old baby
510(k) Premarket Notification - Food and Drug Administration
WebThe BioFire Global Fever Panel detects and identifies selected bacterial, viral, and protozoan nucleic acids directly from EDTA whole blood collected from individuals with … WebBIOFIRE ® SHIELD ™ Control Kit for the BioFire Global Fever Panel (DFA2-ASY-0006) 10,464,060; 10,913,060; and patents pending: TRADEMARK INFORMATION. WebThe BioFire FilmArray System uses a plastic pouch with automated capabilities, including sample preparation, reverse transcription for RNA viruses, and a two-stage nested multiplex PCR process. The results are … how common is the surname gravlin