WebBioFire Diagnostics, LLC BioFire® Respiratory Panel 2.1 (RP2.1) Updated December 22, 2024 Coronavirus Disease 2024 (COVID -19) 1 You are being given this Fact Sheet because your sample(s) was tested for the Coronavirus Disease 2024 (COVID-19) using the BioFire® Respiratory Panel 2.1 (RP2.1). The BioFire RP2.1 is a molecular (PCR) test WebThe BioFire RP2.1 test was performed using the BioFire FilmArray EZ Configuration system according to the manufacturer’s instructions. Briefly, 300 μL of sample was mixed …
BioFire® Respiratory Panel 2.1 (RP2.1) - Instructions …
WebAug 30, 2024 · The BioFire RP2.1-EZ is a multiplexed polymerase chain reaction (PCR) test authorized for use with nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare WebThe FDA De Novo authorized BioFire RP2.1 Panel is a frontline test to help clinicians quickly diagnose respiratory infections, including COVID-19, influenza, RSV, and many … BioFire ® FilmArray ® Respiratory Panels (RP2.1, RP2.1plus and RP2.1-EZ) … 1-800-735-6544; Field Application Specialists. Field Application Specialists … pork fishing baits
FACT SHEET FOR PATIENTS - Food and Drug Administration
WebThe BioFire RP2.1 test was performed using the BioFire FilmArray EZ Configuration system according to the manufacturer’s instructions. Briefly, 300 μL of sample was mixed with sample buffer and injected into a test pouch containing all necessary reagents for nucleic extraction, PCR amplification, and detection of the respective targets. ... WebThe BioFire RP2.1 was granted clearance on March 17, 2024 and determined to be a Class II device [DEN200031]. Table 1 compares the BioFire COVID-19 Test 2 to the BioFire Respiratory Panel 2.1 and outlines the similarities and differences between the two tests. Table 1. Comparison of the BioFire COVID-19 Test 2 and the BioFire Respiratory Panel … WebThe BioFire RP2.1/RP2.1plus Control Panel M441 is intended for in vitro use as reference material to monitor the detection and identification of respiratory viral and bacterial targets in nasopharyngeal swabs (NPS) obtained from individuals suspected of … pork flat iron steak recipes