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SCACM will place your meeting registration in a hat and draw at least one winner of a 2021 or 2022 Complete Audioconference series for those posting any one of the following types of messages on this board. Additionally, researchers, medical technicians, law enforcement officers, and soldiers in the field use company devices to detect or study disease-causing organisms.įor further information, please visit attendees. Disclosures Nicholas Francis, n/a, BioFire Diagnostics. Currently, you will find the latest 100 filings for Premarket Notifications. Note This panel has not been evaluated by the FDA or other regulatory agencies for diagnostic use. governmental agencies including the Department of Health and Human Services and the Department of Defense. This page includes the latest FDA filings for Biofire Diagnostics L L C. The Company has used its extensive patent portfolio to successfully market nearly 200 products to the clinical, research and military markets. BioFire collaborates with various U.S. The Company also currently holds over 70 patents related to polymerase chain reaction (PCR). The Company prides itself in a comprehensive understanding of what matters most to its customers, and continues to make great strides to ensure that its products remain reliable, user-friendly, and on the cutting edge of innovation. BioFire is continuing to develop a broader test menu for its FilmArray system, including a blood culture ID panel, gastrointestinal panel, and a meningitis panel. The Company manufactures and distributes its proprietary diagnostic respiratory panel, FilmArray RP, which operates on its user-friendly FilmArray system, to hospital-based clinical laboratories in the U.S. is a privately held clinical diagnostics company based in Salt Lake City, Utah. In addition to its enthusiasm around the clinical diagnostics space, BioFire will continue to lead in the development of reliable and sensitive biosurveillance products such as its PCR-based biodetection system RAZOR ® EX and the FilmArray BioSurveillance System.īioFire Diagnostics, Inc. Besides the FilmArray RP, the Company is developing similar FilmArray panels for pathogen identification in blood culture, gastrointestinal infections, meningitis and much more. BioFire now provides the only FDA cleared clinical diagnostic test for 8 of the 20 organisms in its panel. The FilmArray Respiratory Panel (RP) is FDA-cleared for 20 viral and bacterial respiratory pathogens. We believe we are in an excellent position to continue building our business by driving growth of our broad molecular diagnostic product portfolio."īioFire Diagnostics will continue to focus on leveraging its novel FilmArray ® pathogen detection system to develop multiplex diagnostic tests for various clinical applications. We have established strong momentum in the diagnostics marketplace and the new branding under BioFire Diagnostics better reflects the markets we serve. "The new name reflects the passion and energy of the Company and management team, and highlights our expanded presence in the clinical diagnostics market. "We are excited to announce our new name to our customers and industry members," said Kirk Ririe, Chief Executive Officer of BioFire Diagnostics. The Company has also re-launched its website ( to reveal its new branding. to more accurately reflect its business strategy and strong momentum in the marketplace. 28, 2012 (GLOBE NEWSWIRE) - Idaho Technology, Inc., today announced it has changed the corporate name to BioFire Diagnostics, Inc. Recently, the FilmArray Respiratory Panel (BioFire Diagnostics Inc, Salt Lake City, UT) became the first FDA- cleared PCR assay with C.