Member since: 2019
Microbiology in a box.
Application Area: Infectious diseases
"Seems easy to use but categorized as high complexity by FDA for use in USA."
Member since: 2013
Organization: Dr. Dang Lab
Very effective platform to rule out the infection
Application Area:Multiplex assays for molecular diagnostics
"Biofire is a vary effective platform to rule out the infection as earlier as 1 hr in. We are doing Respiratory and Gastrointestinal panel."
Member since: 2018
Organization: Torrance Memorial Medical Center
Highly recommended instrument. Ease of use and value for reagent cost.
Application Area:Infectious Disease
"Service from Biofire is exceptional. The multiplex system was an easy decision based on the number of analytes and the ease of specimen preparation. A very good companion to flu season."
Member since: 2018
Organization: Saint Joseph Hospital
Fast, easy, great for patient care.
Application Area:Molecular panel
"The ease of use on this instrument is second to none! The quick TAT allows for the clinicians to treat patients faster and with the right antibiotics! This product has been a saving grace during flu season this past year."
Member since: 2014
Organization: Covenant Medical Center
"We changed from a DFA method to this PCR method. The sensitivity of the PCR is amazing. We are reporting more pathogens and providing the information in a more timely manner."
The BioFire® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 is now authorized under an EUA for use on both the BioFire 2.0 and BioFire Torch Systems. In addition to the detection of SARS-CoV-2, the BioFire RP2.1 detects 21 additional respiratory pathogens to help clinicians quickly rule in and rule out other common causes of respiratory illness in about 45 minutes. BioFire also intends to submit the BioFire RP2.1 Panel to the FDA for de novo clearance on an accelerated timeline.
About Emergency Use Authorization:
This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.