Biofire global fever
The 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 a revolutionary detection system in a lightweight, small-footprint format. WebBioFire Defense, LLC Cynthia Phillips VP of Regulatory, Quality, and Clinical Affairs ... Trade/Device Name: FilmArray Global Fever Panel External Control Kit Regulation Number: 21 CFR 866.3920 Regulation Name: Assayed quality control material for clinical microbiology assays Regulatory Class: Class II Product Code: PMN Dated: August 19, …
Biofire global fever
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WebThe BioFire Global Fever Panel has been granted De Novo classification by the US FDA for the detection of chikungunya virus, dengue virus (serotypes 1-4), Leptospira spp., and Plasmodium spp. from individuals with signs and/or symptoms of AFI and known or suspected exposure to target pathogens. WebSep 1, 2024 · We aimed to evaluate the performance of the BioFire Global Fever Panel (GF Panel), a multiplex nucleic acid amplification test performed on whole blood …
WebApr 3, 2024 · device to detect and identify selected microbial agents that cause acute febrile illness. 22. De Novo Number. DEN200043. Device Name. FilmArray Global Fever Panel. Requester. BioFire Defense, LLC. 79 west 4500 south. WebBioFire® Respiratory 2.1 (RP2.1) Panel. Now the first FDA De Novo authorized test for COVID-19, the BioFire RP2.1 Panel detects 22 respiratory pathogens, including SARS …
WebApr 3, 2024 · The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel are Chikungunya virus, CCHF virus, dengue virus … 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 …
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WebMake lunch hour count at #ECCMID2024! 📅 On April 16, join us for our Integrated Symposium: The value of diagnostic information for #antimicrobialstewardship… flying with a snowboard on deltaWebThe BioFire Global Fever Special Pathogens Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplexed polymerase chain reaction … flying with a snowboard southwestWebNov 18, 2016 · The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the U.S. Department of Defense and NIAID, uses an automated, … green mountain maple pecan k-cupWebFilmArray 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: ... flying with a service dog united airlineshttp://biofireinc.com/ flying with a snowboardWebContractor: Biofire Defense, LLC 79 W 4500 S, STE 14 SALT LAKE CITY, UT, 84107-2663 Phone # 801-262-3592 Fax # 801-447-6907 Web Site: www.biofiredefense.com ... 334516 DFA2-ASY-0003 Global Fever Panel RUO 6 pk – The Global Fever Panel Research Use Only Panel tests for 19 bacterial, viral and protozoan targets from green mountain marathon 2021WebBioFire® 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 … flying with a stopover luggage