Biofire torch base
WebMedical Device Advisory Notice: Pouch Module Software Update. This electronic form is to confirm acknowledgement of the Medical Device Advisory Notice that was mailed to BioFire ® FilmArray ® Torch customers titled: “Medical Device Advisory Notice: Pouch Module Software Update“. *All Fields are Required. WebThe FilmArray Torch is a modification of FilmArray 2.0 and is composed of two to twelve FilmArray. Torch Modules connected to a FilmArray Torch System Base running FilmArray Torch software. The. FilmArray Torch …
Biofire torch base
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WebJan 20, 2016 · Croissance des ventes de 80 % et expansion rapide de la base installée; ... Soumission à la FDA du nouveau système à haute cadence FilmArray® Torch; ... L’acquisition de BioFire contribue activement à la croissance du Groupe et délivre des résultats supérieurs à notre plan d’acquisition. Forte du dynamisme de ses gammes ... WebApr 3, 2024 · 510 (k) Number. K160462. Device Name. FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch. Applicant. BIOFIRE DIAGNOSTICS, LLC. 390 WAKARA WAY. SALT LAKE CITY, UT 84108. Applicant Contact.
WebJul 1, 2024 · The BioFire Torch will be compatible with all existing BioFire FilmArray Panels, providing the quick, comprehensive, and accurate results you have come to expect from BioFire products. Reduced footprint … WebBioFire 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
WebThe BioFire COVID-19 Test is a qualitative test for use with the BioFire FilmArray 2.0 or Torch systems for the detection of SARS-CoV-2 RNA in upper respiratory …
WebThe BioFire COVID-19 Test 2 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 COVID-19 Test 2 consists of the BioFire COVID-19 Test 2 pouch which contains freeze-dried reagents to perform nucleic acid purification and nested, thomas dae leeWebFeb 25, 2016 · The FilmArray® Torch is the latest advancement in syndromic infectious disease testing from BioFire Diagnostics. Providing up to six times more sample throughput compared to the existing system, the high throughput FilmArray® Torch is a fully integrated, random and continuous access multiplex PCR [2] system designed to meet the … thomas dagg mdWebFast and comprehensive, the BIOFIRE RP2.1 Panel offers a run time of about 45 minutes, enabling high efficiency and throughput on the BIOFIRE ® FILMARRAY ® 2.0 and the BIOFIRE ® FILMARRAY ® TORCH Systems. Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. thomas dachelet lawyerWebThe BioFire Torch will be compatible with all existing BioFire FilmArray Panels, providing the quick, comprehensive, and accurate results you have come to expect from BioFire products. Escalable from 1 to 12 Pouch Running Units. Reduced footprint provides up to six times the throughput per square foot of laboratory bench space. ufc pc onlineWebBioFire Diagnostics, LLC . FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch . Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. Submitted by: BioFire Diagnostics, LLC. 390 Wakara Way thomas dagoneauWebJan 12, 2016 · Scalable by design, the 2-module base configured FilmArray® Torch is capable of testing up to 42 patient samples per day, while the 12-module, fully configured FilmArray® Torch is capable of testing up to 262 patient samples per day3. ... BioFire announced its intention to seek 510(k) clearance of the FilmArray® Torch for use with all ... thomas dachser str malschWebA new pouch module option called C. difficile Select* gives users running the BIOFIRE GI Panel on either the BIOFIRE ® FILMARRAY ® TORCH or the BIOFIRE ® FILMARRAY ® 2.0 System the choice to either always report or never report C. difficile results. *C. difficile Select is available only to customers in the US. thomas daelen