FDA Lists Bio-Rad’s CFX96 Dx Real-Time PCR System for IVD Testing

Print

Date: 05/18/2020

HERCULES, Calif. – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global leader of life science research and clinical diagnostic products, today announced that its CFX96 Dx Real-Time PCR System has been listed with the U.S. Food and Drug Administration (FDA) for IVD testing and may be used to help in the diagnosis of COVID-19. The FDA listing extends access to the instrument to assay developers and testing laboratories in the U.S.

Throughout the COVID-19 pandemic, the CFX96 Dx Real-Time PCR System has been used by laboratories outside the U.S. that require an IVD platform to detect SARS-CoV-2. The system has also met the CE mark requirements for IVD use in Europe and is registered with regulatory bodies for IVD use in many other countries.

"We are pleased our CFX96 Dx Real-Time PCR System is now available for COVID-19 testing in U.S. markets," said Annette Tumolo, Bio-Rad Executive Vice President, President, Life Science Group. "By identifying those who test positive for the virus, individuals can be quarantined and receive treatment more quickly, helping to contain the spread of this disease."

The CFX96 Dx Real-Time System joins other Bio-Rad products that are being used for the detection of COVID-19, including Bio-Rad's SARS-CoV-2 Droplet Digital PCR (ddPCR) Kit; Platelia SARS-CoV-2 Total Ab assay; and the SARS-CoV-2 Standard, which is used to support laboratory assay validation of COVID-19 testing.

BIO-RAD, DROPLET DIGITAL, and DDPCR are trademarks of Bio-Rad Laboratories, Inc., in certain jurisdictions.

About Bio-Rad
Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostic markets. With a focus on quality and customer service for over 65 years, our products advance the discovery process and improve healthcare. Our customers are university and research institutions, hospitals, public health and commercial laboratories, biotechnology, pharmaceutical, as well as applied laboratories that include food safety and environmental quality. Founded in 1952, Bio-Rad is based in Hercules, California, and has a global network of operations with more than 8,100 employees worldwide. Bio-Rad had revenues exceeding $2.3 billion in 2019. For more information, please visit bio-rad.com.

This release may be deemed to contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements we make regarding our expectations regarding our products. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "plan", "believe," "expect," "anticipate," "may," "will," "intend," "estimate," "continue," or similar expressions or the negative of those terms or expressions, although not all forward-looking statements contain these words. Such statements involve risks and uncertainties, which could cause actual results to vary materially from those expressed in or indicated by the forward-looking statements. These risks and uncertainties include the duration, severity and impact of the COVID-19 pandemic, our ability to develop and market new or improved products, our ability to compete effectively, international legal and regulatory risks, supply chain issues, and product quality and liability issues. For further information regarding our risks and uncertainties, please refer to the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Bio-Rad's public reports filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. Bio-Rad cautions you not to place undue reliance on forward-looking statements, which reflect an analysis only and speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

Press Contact:
Bio-Rad Laboratories, Inc.
Tina Cuccia, Corporate Communications
510-724-7000
tina_cuccia@bio-rad.com

Sign Up for Bio-Rad Updates!
Enter your email address below to receive your choice of the latest news, promotions, and more.
Get Help
FDA-Lists-Bio-Rad-s-_1589584655 [x-forwarded-proto] = [https] [accept-language] = [en-US,en;q=0.5] [x-forwarded-port] = [443] [x-forwarded-for] = [3.235.172.213, 10.232.18.145] [accept] = [text/html,application/xhtml+xml,application/xml;q=0.9,*/*;q=0.8] [seourl] = [/en-us/life-science-research/news/fda-lists-bio-rads-cfx96-dx-real-time-pcr-system-for-ivd-testing] [x-amzn-trace-id] = [Root=1-5ed4556c-0cbc6202953d41628280ceb8] [x-forwarded-server] = [lsds-prod-s.br.aws-livesite.io] [x-forwarded-host] = [www.bio-rad.com] [x-query-string] = [ID=FDA-Lists-Bio-Rad-s-_1589584655] [host] = [10.232.1.21:1776] [x-request-uri] = [/en-us/life-science-research/news/fda-lists-bio-rads-cfx96-dx-real-time-pcr-system-for-ivd-testing] [connection] = [Keep-Alive] [accept-encoding] = [br,gzip] [user-agent] = [CCBot/2.0 (https://commoncrawl.org/faq/)] Vertical/VerticalArticleDetail pageStyleKey life-science-research/news/fda-lists-bio-rads-cfx96-dx-real-time-pcr-system-for-ivd-testing LSR https://www.bio-rad-antibodies.com https://www.bio-rad.com 03/26/14 02:17 PM en_US true internet/generic 2019-07-09 16:59:23 /default/main/bio-rad/STAGING 1385504243813 US templatedata/internet/generic/data/en_US/GNL/page_generic_footer_b2c_1385505294_US.xml page_generic_footer_b2c /default/main/bio-rad/WORKAREA/default jc7v8okm 2017-10-27 13:13:40 true Done jc7v8okm templatedata/internet/generic/data/en_US/GNL/page_generic_footer_b2c_1385505294_US.xml GNL N /default/main/bio-rad en_US 11/27/23 02:18 PM 1561946660551 2019-07-09 16:59:23 /default/main/bio-rad/WORKAREA/default/templatedata/internet/generic/data/en_US/GNL/page_generic_footer_b2c_1385505294_US.xml footer 1 1385504243813 page_generic_footer_b2c <div class="col"> <h4>Support</h4> <ul> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/life-science-research/support?ID=1140">Life Science Support</a></li> <li><a class="wtclass linkgeneration" href="_acdDomain/technical-support.html">Antibodies Support</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/life-science-research/purchase-service-programs/expert-care-service?ID=1383780912356">Expert Care Service</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/contact">Contact Us</a></li> </ul> </div> <div class="col"> <h4>Documents</h4> <ul> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/literature-library">Literature Library</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/life-science-research/support/certificate-of-analysis">Certificate of Analysis</a></li> <li><a class="wtclass" href="https://myeinserts.qcnet.com/" target="_blank" rel="noopener noreferrer">QC Inserts</a></li> <li><a class="wtclass linkgeneration" href="_acdDomain/iso-9001-quality-assurance-management.html">Quality Certification</a></li> </ul> </div> <div class="col"> <h4>Ordering</h4> <ul> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/my-bio-rad">Quick Order</a></li> <li><a id="footer_orderLink" class="orderhistoryLink wtclass" href="javascript:void(0);">Order History</a></li> <li><a class="wtclass" id="footer_quoteLink" href="javascript:void(0);">Quote History</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/my-bio-rad">My Bio-Rad</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/life-science-research/purchase-service-programs/supply-center-program?ID=1383773882551">Supply Centers</a></li> </ul> </div> <div class="col"> <h4>Our Products</h4> <ul> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/life-science-research?ID=1100">Life Science Research</a></li> <li><a class="wtclass linkgeneration" href="_acdDomain/">Antibodies</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/clinical-diagnostics?ID=1200">Clinical Diagnostics</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/spectroscopy?ID=1300">Spectroscopy</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/process-separations?ID=1400">Process Separations</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/food-science?ID=1475">Food Science</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/education?ID=1450">Life Science Education</a></li> </ul> </div> <div class="col"> <h4>Company</h4> <ul> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/corporate/about-bio-rad?ID=1003">About Bio-Rad</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/corporate/careers?ID=1004">Careers</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/corporate/investor-relations?ID=1007">Investor Relations</a></li> <li><a class="wtclass linkgeneration" href="_brcDomain/_locale/corporate/newsroom?ID=1006">Newsroom</a></li> <li><a class="wtclass linkgeneration" href="_acdDomain/blog/">Blog</a></li> <li><a class="wtclass" target="_blank" href="https://www.bioradiations.com" rel="noopener noreferrer">Bioradiations</a></li> <li> <div class="social"> <ul> <li><a class="no-target-style brconly wtclass" href="https://www.linkedin.com/company/bio-rad?trk=top_nav_home" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/linkedin_round_40x40.png" alt="Bio-Rad LinkedIn" width="20" height="20" /></a> <a class="no-target-style bracd wtclass" style="display: none;" href="https://www.linkedin.com/company/bio-rad-antibodies" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/linkedin_round_40x40.png" alt="Bio-Rad Antibodies LinkedIn" width="20" height="20" /></a></li> <li><a class="no-target-style brconly wtclass" href="https://www.youtube.com/user/BioRadLifeScience" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/youtube-icon-rnd-40x40.png" alt="Bio-Rad YouTube" width="20" height="20" /></a> <a class="no-target-style bracd wtclass" style="display: none;" href="https://www.youtube.com/playlist?list=PLrAEgIY86I6w1jajKp3O9RQJEvJZ2ux0I" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/youtube-icon-rnd-40x40.png" alt="Bio-Rad Antibodies YouTube" width="20" height="20" /></a></li> <li><a class="no-target-style brconly wtclass" href="https://twitter.com/BioRadLifeSci" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/twitter_round_40x40.png" alt="Bio-Rad Twitter" width="20" height="20" /></a> <a class="no-target-style bracd wtclass" style="display: none;" href="https://twitter.com/BioRadAbs" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/twitter_round_40x40.png" alt="Bio-Rad Antibodies Twitter" width="20" height="20" /></a></li> <li><a class="no-target-style brconly wtclass" href="https://www.facebook.com/biorad/" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/facebook-icon-rnd-40x40.png" alt="Bio-Rad Facebook" width="20" height="20" /></a> <a class="no-target-style bracd wtclass" style="display: none;" href="https://www.facebook.com/BioRadAntibodies" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/facebook-icon-rnd-40x40.png" alt="Bio-Rad Antibodies Facebook" width="20" height="20" /></a></li> <li><a class="no-target-style wtclass" href="https://www.instagram.com/bioradlabs/" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/instagram-icon-rnd-40x40.png" alt="Bio-Rad Instagram" width="20" height="20" /></a></li> <li><a class="no-target-style wtclass" href="https://uk.pinterest.com/BioRadAbs/" target="_blank" rel="noopener noreferrer"><img src="https://www.bio-rad.com/webroot/web/images/general/icons/pinterest40x40.png" alt="Bio-Rad Pinterest" width="20" height="20" /></a></li> </ul> </div> </li> </ul> </div> /webroot/web/html footer_page_b2c_en_US.html /webroot/web/html/footer_page_b2c_en_US.html Karen Moss Footer page Footer 03/26/14 02:17 PM 11/27/23 02:18 PM US en GNL /GNL N 0 en-us Home <script type="text/javascript">$(document).ready(function() { var region = $("#headlangID .lang strong").html(); $(".footer-nav > a:nth-child(3)").after(" | <a href='https://www.bio-rad.com/webroot/web/html/featured/en/web-accessibility.html' id='regionlink'>Web Accessibility</a>");});</script>Trademarks Site Terms Terms & Conditions Imprint EU Recycle Program Transparency Information Privacy Change Cookie Setting <script type="text/javascript">$(document).ready(function () {$(".links2").append('<style>.social-links-br {float: left;margin-right: 10px;}.social-links-br img {width: 20px;height: 20px;margin-right: 5px}</style><div class="social-links-br"><a class="no-target-style" href="https://www.linkedin.com/company/bio-rad?trk=top_nav_home" target="_blank"><img src="/webroot/web/images/general/icons/linkedin_round_40x40.png" alt="Bio-Rad LinkedIn"></a><a class="no-target-style" href="https://www.youtube.com/user/BioRadLifeScience" target="_blank"><img src="/webroot/web/images/general/icons/youtube-icon-rnd-40x40.png" alt="Bio-Rad YouTube"></a><a class="no-target-style" href="https://twitter.com/BioRadLifeSci" target="_blank"><img src="/webroot/web/images/general/icons/twitter_round_40x40.png" alt="Bio-Rad Twitter"></a><a class="no-target-style" href="https://www.facebook.com/biorad/" target="_blank"><img src="/webroot/web/images/general/icons/facebook-icon-rnd-40x40.png" alt="Bio-Rad Facebook"></a><a class="no-target-style" href="https://www.instagram.com/bioradlabs/" target="_blank"><img src="/webroot/web/images/general/icons/instagram-icon-rnd-40x40.png" alt="Bio-Rad Instagram"></a></div>');});</script>&copy; {0} Bio-Rad Laboratories, Inc. This page was last edited on {0} true True GTM-MJ2DN2S us US en LSR life-science-research life-science-research /prd/en/US/direct/biorad?ts=1&cmd=OrdersWorkspaceDisplay /prd/en/US/direct/biorad?ts=1&cmd=QuotesWorkspaceDisplay /prd/en/US/direct/biorad?ts=1&cmd=InvoiceWorkspaceDisplay&_Tab=Invoice false false true true false 1040988879 LHsYCOu_wQMQz_Ww8AM window.google_tag_params true 272-THL-329 EU_COOKIE_PREFS CartID_ WT_FPC <script type="text/javascript">$.ajax({url: document.location.protocol + '//munchkin.marketo.net/munchkin.js',dataType: 'script',cache: true,success: function() {Munchkin.init('272-THL-329');}});</script> <script type="text/javascript" src="https://www.bio-rad.com/evportal/framework/skins/evolution/js/proxyMunchkin.js"></script> 2020 {"country":"us","b2b_punch_out_mode":"","pageType":"other","user_id":"","visitorLoginState":false,"visitorType":"","sessionType":"B2C","language":"en","vertical":"LSR","b2b_org_id":""} 0 0 0