Biofire respiratory 2.1 package insert

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August undefined, 2024

WebMay 4, 2024 · The inclusion of SARS-CoV-2 in the BIOFIRE® RP2.1 panel allows healthcare providers to quickly identify patients with common respiratory pathogens, as well as those with COVID-19, using one simple test. The BIOFIRE® RP2.1 panel takes approximately 45 minutes and tests nasopharyngeal swab samples in transport media. WebDec 2, 2024 · The BioFire RP2.1 is intended for use by laboratory personnel who have received specific training on the use of the FilmArray 2.0 and/or the FilmArray Torch Systems. The BioFire RP2.1 is only for use under the Food and Drug Administration’s Emergency Use Authorization. SUMMARY AND EXPLANATION OF THE TEST.

Respiratory Pathogen Panel Test BioFire Diagnostics

WebBioFire® COVID-19 Test 2 1 510(k) Summary I. Submitter BioFire Defense, LLC Salt Lake City, UT 84107 . Phone: (801) 262-3592 . Contact Person: Cynthia L. Phillips . ... The 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 pouch WebThe BioFire RP2.1 is a real-time, nested multiplexed polymerase chain reaction test designed to simultaneously identify nucleic acids from 22 different viruses and bacteria … cyphercraft

NATtrol™ Respiratory Panel 2.1 (RP2.1) Controls - ZeptoMetrix

WebThe BioFire® COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS … WebPanel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus) et le BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) effectués sur les systèmes BioFire® FilmArray®. Ce produit n’est pas destiné à remplacer les contrôles du fabricant fournis avec l’appareil. PRÉSENTATION et PRINCIPE DU PRODUIT : Le BioFire RP2.1/RP2.1plus Control ... Webmulti-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents: De Novo Number: DEN200031: Device Name: BioFire Respiratory Panel 2.1 (RP2.1) Requester: Biofire Diagnostics, LLC: 515 colorow drive: salt lake city, UT 84108 Contact: kristen j kanack: Regulation Number: 866.3981: Classification Product Code: cypher cosplay

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION …

BIOFIRE Respiratory 2.1-EZ Panel (EUA)* Pioneering …

WebMar 18, 2024 · The BIOFIRE ® RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract … WebThe new BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel enables rapid and accurate automated detection of pathogens behind respiratory infections. It tests for 19 viruses … cypher crackerWebBioFire Respiratory Panel 2.1 (RP2.1), BioFire Respiratory Panel 2.1 plus (RP2.1 plus) and BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on BioFire FilmArray systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire cyphercrescent

"WebVisit our site and order respiratory panels 2.1 vials from zeptometrix.com. Respiratory Panel 2.1 (RP2.1) Controls (12 x 0.3mL) - Log in for Price. Add to Cart (800) 274-5487. ... The product has been tested with the BioFire® FilmArray® system and provides the expected results, however performance characteristics must be established by the ... " - Biofire respiratory 2.1 package insert

Biofire respiratory 2.1 package insert

BioFire® FilmArray® Product Support Documents BioFire …

WebBioFire® Respiratory Panel 2.1 (RP2.1), BioFire® Respiratory Panel 2.1plus (RP2.1plus) and BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ) assays performed on the BioFire® FilmArray® systems. BioFire RP2.1/RP2.1plus Positive control is composed of synthetic RNA transcripts specifically designed for and intended to be used solely with the BioFire WebFeb 24, 2024 · The BioFire Respiratory Panel 2.1 ... (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary. 3 Abbreviations:

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WebThe BioFire Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BioFire FilmArray 2.0 or BioFire FilmArray Torch systems for … WebWarnings and Precautions section of the RP2 Package Insert. There is a risk of false positive results due to non-specific amplification and cross-reactivity with organisms found in the respiratory tract. Observed and predicted cross-reactivity for BioFire RP2.1 is described in the Analytical Specificity section of the RP2 Package Insert.

WebMar 18, 2024 · The BIOFIRE® RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract infection, using one simple test. The BIOFIRE® RP2.1 Panel yields results in approximately 45 minutes using nasopharyngeal swab (NPS) samples in transport media or saline. WebThe BioFire COVID-19 Test is also for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to eight saliva specimens or up to eight upper respiratory specimens ...

WebJan 16, 2024 · The addition of a widely used simultaneous sample-to-answer SARS-CoV-2 RT-PCR assay will contribute to the number of medical laboratories able to test for … WebRespiratory 2.1-EZ (RP2.1- EZ) Panel (EUA)*. The BIOFIRE RP2.1-EZ Panel (EUA)* uses a syndromic approach to quickly identify SARS-CoV-2, along with 18 additional viral and …

WebProtocols for Laboratory Verification of Performance of the BioFire ® Respiratory 2.1 (RP2.1) Panel Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Tech …

cypher credit unionWebThe BIOFIRE® Respiratory RP2.1 (RP2.1) Panel accurately identifies 22 of the pathogens most commonly associated with respiratory infections, including SARS-CoV-2. Fast and … cypher create new databaseWebTrade/Device Name: BioFire Respiratory Panel 2.1 (RP2.1) Regulation Number: 21 CFR 866.3981 Regulation Name: Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test Regulatory Class: Class II cypher crescentWebThe BioFire RP2.1/RP2.1plus Control Panel M441 is comprised of 12 single use tubes, 6 tubes of BioFire RP2.1/RP2.1plus Positive and 6 tubes of BioFire RP2.1/RP2.1plus Negative, 300µL each. BioFire RP2.1/RP2.1plus Positive control contains synthetic RNA suspended in a non-infectious solution of buffers, preservatives and stabilizers. cypher costumeWebMar 18, 2024 · The BIOFIRE® RP2.1 Panel allows healthcare providers to quickly identify common respiratory pathogens found in patients presenting with acute respiratory tract … cypher cqlWebMar 18, 2024 · BIOFIRE ® Respiratory 2.1-EZ Panel: this panel identifies 19 pathogens associated with respiratory infections, including SARS-CoV-2 in approximately 45 minutes, and is used in point of care and ... cypher create pathWebMay 4, 2024 · bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary specialized in syndromic infectious disease testing, has received Emergency Use Authorization by the U.S. Food and Drug Administration for the BIOFIRE® RP2.1 panel, which includes 22 pathogens that cause respiratory … cypher craft