WebSimple, comprehensive meningitis/encephalitis testing. The BIOFIRE ® FILMARRAY ® Meningitis/Encephalitis (ME) Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens responsible for community acquired meningitis or encephalitis including viruses, bacteria and yeast. The Panel received FDA De Novo clearance in October … WebThe BioFire COVID-19 Test 2 and the BioFire Respiratory Panel 2.1 (RP2.1) are substantially equivalent. The BioFire COVID-19 Test 2 is essentially a BioFire RP2.1 …
Respiratory Pathogen Panel Test BioFire Diagnostics
WebThe BioFire JI Control Panel M420 is intended for use as an external quality control to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Gram positive and Gram negative bacteria, antibiotic resistance genes and yeast pathogens when tested by the BioFire ® Joint Infection Panel assay … WebMay 18, 2024 · In this multicenter evaluation, we assessed the performance characteristics of the BioFire RP2.1 for the detection of SARS-CoV-2. One or more targets on the panel were detected in 19.3% (101/524) of specimens tested, with SARS-CoV-2 detected in 12.6% (66/524) of specimens. Human rhinovirus/enterovirus was also detected in 32.7% … re4 punisher vs sg09
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …
WebThe BioFire RP2.1-EZ Panel (EUA)* is a syndromic test with the ability to identify 15 viral and 4 bacterial respiratory pathogens in patients suspected of SARS-CoV-2. As the name implies, it’s easy and takes just one … WebThe BioFire® COVID-19 Test is a nested multiplexed real-time RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal swabs in transport media from individuals suspected of COVID-19 by their healthcare provider. For In Vitro Diagnostic Use Click Here for Details BioFire ® Global Fever Panel 1 Clinical Test. 6 Targets. Web(RP2.1), a prescription device with the following indications for use: The BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the … re4 professional mode remake