IRVINE, CA. –\u00a0News Aktuell – 12 April
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Fluxergy’s platform
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Fluxergy has made
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Last year, Fluxergy
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“Fluxergy is
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Fluxergy’s potential for multimodality of its platform raises important questions:
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For more
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Disclaimer<\/b><\/p>\n
The Fluxergy Test Kit COVID-19 is only
IRVINE, CA. –\u00a0News Aktuell – 12 April
2021 –\u00a0Fluxergy, Inc., a medical diagnostic testing platform company with
a detection technology solution capable of multimodality, announced today that
it has obtained CE marking for its one-hour COVID-19 RT-PCR test, to use by
healthcare professionals as an in vitro diagnostic (IVD) for the
detection of SARS-CoV-2. The …<\/p>\n","protected":false},"author":1,"featured_media":13981,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[60],"tags":[],"_links":{"self":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/13980"}],"collection":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/comments?post=13980"}],"version-history":[{"count":0,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/13980\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media\/13981"}],"wp:attachment":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media?parent=13980"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/categories?post=13980"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/tags?post=13980"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n2021 –\u00a0Fluxergy, Inc.<\/a>, a medical diagnostic testing platform company with
\na detection technology solution capable of multimodality, announced today that
\nit has obtained CE marking for its one-hour COVID-19 RT-PCR test, to use by
\nhealthcare professionals as an in vitro<\/i> diagnostic (IVD) for the
\ndetection of SARS-CoV-2. The CE-mark will allow Fluxergy’s innovative testing
\nplatform to enter the European Union market and any other markets that accept
\nCE-marking as valid regulatory approval. <\/p>\n![](\"https:\/\/release.media-outreach.com\/release.php\/Images\/Thumb\/500x0\/140196\/image.jpg#image-140196\")
<\/p>\nThe Fluxergy Diagnostic System: The Fluxergy Analyzer, which conducts the testing; the Fluxergy Card, a single-use test cartridge and its reagents; and the FluxergyWorks software, to manage the test data. The Fluxergy Test Kit COVID-19 is only available for purchase in the European Union market and any other markets that accept the CE-marking as valid regulatory approval. COURTESY: FLUXERGY, INC.<\/span><\/h5>\n
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\nis an automated, sample-to-answer testing platform with multimodal capability
\nallowing for a variety of assay types, such as molecular, immunochemistry,
\nchemistry, and cytometry assays, to be run simultaneously on the same
\ncartridge. This will give users the ability to run unique Point-of-Care (PoC)
\npanels with the potential ability to do built-in reflex testing, among other capabilities.
\nPotential environments for rapid testing applications include emergency
\nrooms, outpatient procedures, urgent care, workplace screening, mobile and
\ncommunity level testing settings. <\/p>\n
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\nits platform available as Research Use Only (RUO) system for its partners,
\nincluding University of California San Diego (San Diego, CA, USA) and Mass
\nGeneral Brigham (Boston, MA, USA), during the public health emergency. In December
\n2020, Fluxergy received dual ISO-13485:2016 and MDSAP certifications. <\/p>\n
\n
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\nreceived a $30 million investment from John Tu, principal investor and Kingston
\nTechnology co-founder, to rapidly expand its capability to scale production of
\nthe Fluxergy Analyzer diagnostic testing system in response to the COVID-19
\npandemic. Fluxergy has now expanded manufacturing capabilities for its testing
\nsystem to up to one million per month. <\/p>\n
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\nseeking commercial partnerships with healthcare providers and international
\ngo-to-market partners in Europe, Asia, and Australia”, states Fluxergy’s Chief
\nCommercial Officer, Dr. Ali Tinazli, responsible for global sales.<\/p>\n
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\nHow will decentralized testing at the point-of-need become a key enabler for
\ntelemedicine? What platforms, technologies, and workflows do we need to be
\nbetter prepared for the next pandemic? To what extent does telemedicine with
\nthe diagnostic data unlock new healthcare opportunities such as in preventive
\nmedicine? <\/p>\n
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\ninformation, contact Richard Laermer (+1-212-741-5106 X216; fluxergy@RLMpr.com<\/a>) and visit www.fluxergy.com<\/a>.<\/p>\n
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\navailable for purchase in the European Union
\nmarket and any other markets that accept the CE-marking as valid regulatory
\napproval.<\/p>\n<\/p><\/div>\n\n
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