![]() ![]() BioFire COVID-19 Test Pouch Module Installation InstructionsīioFire COVID-19 Test v1.IFU Updated: May 2022 Quick Guide Updated: June 2021ĭownload the BioFire COVID-19 Test v1.1 Information SheetīioFire COVID-19 Software Pouch Module for v1.1 (Updated May 2022) Quick Guide BIOFIRE SHIELD Control Kit for the BioFire COVID-19 Test v1.1 (PDF, 3 MB).BIOFIRE SHIELD Control Kit Instructions for use for the BioFire COVID-19 Test v1.1 (PDF, 1 MB) BioFire Diagnostics, LLC Jul 2018 - Present4 years 11 months Baltimore, Maryland Area Senior Territory Sales Manager responsible for sale of BioFire's FilmArray System which helps healthcare.Instructions for Use and Quick Guides are found in the table aboveīIOFIRE ® SHIELD ™ Control Kit for the BioFire COVID-19 Test v1.1 (6 control vials) Quick Guide for BioFire COVID-19 Test v1.1 for Lower Respiratory Testing.Quick Guide for BioFire COVID-19 Test v1.1 for Upper Respiratory or Saliva Testing.BioFire COVID-19 Test v1.1 Instructions for Use (IFU).Healthcare Provider Fact Sheet (PDF, 327 KB)ĭeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Coronavirus (COVID-19).The EUA (Emergency Use Authorization) for the BioFire COVID-19 Test enables CLIA moderate and high complexity laboratories to conduct a PCR test for SARS-CoV-2 in-house, providing results in approximately one hour. The BioFire COVID-19 Test is a nested multiplexed RT-PCR test intended for the qualitative detection of SARS-CoV-2 RNA in samples from individuals suspected of COVID-19 by their healthcare provider. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner. The Salt Lake City-based company was founded in 1990. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. Biofire Diagnostics, LLC is a biotechnology company that provides syndromic infectious disease diagnostic services. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens and BioFire Diagnostics is now the Center of Excellence for Molecular Diagnostics and responsible for manufacturing, marketing and sales of the FilmArray system. This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories ![]()
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