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FDA Updates

FDA Authorizes Emergency Use of Ebola Test, August 5, 2014
http://www.fda.gov/medicaldevices/safety/emergencysituations/ucm161496.htm#ebola

Verigene(R) Enteric Pathogens Test Receives FDA Clearance, June 24, 2014
http://www.nanosphere.us/press-release/verigene-enteric-pathogens-test-receives-fda-clearance

Alere Receives FDA Clearance for i Influenza A and B Test, June 16, 2014
http://news.alere.com/~/media/Files/A/Alere-Newsroom/press-release/Alere_i_US_release_6_16_2014.pdf

Quidel Receives FDA Clearance for HSV/VZV Assay, May 14, 2014
http://ir.quidel.com/phoenix.zhtml?c=94060&p=irol-newsArticle&ID=1931016&highlight=

BD MAX Enteric Bacterial Panel Receives FDA Clearance, May 7, 2014
http://bd.com/press-details/10448/The-BD-MAX%E2%84%A2-Enteric-Bacterial-Panel-Receives-FDA-Clearance-to-Detect-the-Most-Common-Causes-of-Bacterial-Gastroenteritis

FDA Approves First Molecular Blood Type Test by Immucor, May 22, 2014
http://investor.immucor.com/releasedetail.cfm?ReleaseID=850211

FDA Approves Roche's HPV Test for First Ever Primary Screening for Cervical Cancer, April 25, 2014
http://www.roche.com/media/media_releases/med-cor-2014-04-25.htm

BioFire's Filmarray Gastrointestinal Panel received FDA Clearance, May 5, 2014
http://www.biomerieux-usa.com/servlet/srt/bio/usa/dynPage?open=USA_NWS_NWS&doc=USA_NWS_NWS_G_PRS_RLS_199&crptprm=ZmlsdGVyPQ==

Meridian receives FDA approval for their isothermal Pertussis test, March 31, 2014
http://www.meridianbioscience.com/diagnostic-products/respiratory/illumigene-molecular-diagnostic-system/illumigene-pertussis.aspx

Nanosphere’s Antibiotic-Resistant Bacteria Test Cleared, January 11, 2014
http://www.nanosphere.us/news/nanosphere-receives-fda-clearance-gram-negative-bacteria-test

Quidel Strep Test Cleared, December 30, 2013
http://ir.quidel.com/phoenix.zhtml?c=94060&p=irol-newsArticle&ID=1887212&highlight=

FDA Clears Cobas CT/NG v2.0 (Roche, Indianapolis, IN) for four additional female specimen types, December 4, 2013
http://molecular.roche.com/News/LocalNews/Pages/RochereceivesFDAclearancetouseadditionalspecimentypesforchlamydiaandgonorrheatest.aspx

Bruker receives FDA clearance for identification of gram-negative identification organisms using MALDI Biotyper CA System, November 26, 2013
http://www.bruker.com/news-records/single-view/article/bruker-corporation-announces-fda-clearance-to-market-the-maldi-biotyper-ca-system.html

Illumina Inc's Genome sequencing system with two Cystic Fibrosis assays, MiSeqDx, cleared by the FDA, November 19, 2013
http://investor.illumina.com/phoenix.zhtml?c=121127&p=irol-newsArticle&ID=1878430&highlight=

FDA Clears IMDx C. difficile Test, November 12, 2013
http://www.intelligentmdx.com/press/news-releases/bid/324750/IntelligentMDx-Receives-FDA-Clearance-for-IMDx-C-difficile-for-Abbott-m2000-Assay-Completes-Move-of-Corporate-Headquarters-to-Waltham

Hologic's HPV Genotype Assay Approved for Panther System, November 7, 2013
http://investors.hologic.com/2013-11-07-FDA-Approves-Aptima-HPV-16-18-45-Genotype-Assay-for-Use-on-Hologics-Panther-System

FDA Clears IMDx Test for Flu A/B and RSV, September 10, 2013
http://www.intelligentmdx.com/press/news-releases/bid/314876/IntelligentMDx-Receives-FDA-Clearance-for-IMDx-Flu-A-B-and-RSV-for-Abbott-m2000-assay

Cepheid Xpert MTB/RIF has been approved for Rapid Tuberculosis Test, July 25, 2013
http://ir.cepheid.com/releasedetail.cfm?ReleaseID=780520

FDA Approves Aptima HPV Assay for Use on Hologic's Panther System, July 23, 2013
http://investors.hologic.com/2013-07-23-FDA-APPROVES-APTIMA-HPV-ASSAY-FOR-USE-ON-HOLOGICS-PANTHER-SYSTEM

VITEK MS Approved as Automated Identification of Bacteria and Yeasts, August 21, 2013
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm365907.htm

Alere Determine Approved as Rapid Diagnostic Test, August 8, 2013
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm364480.htm

Updated Xpert MRSA/SA Blood Culture Test, June 27, 2013
http://ir.cepheid.com/releasedetail.cfm?ReleaseID=774130

First HCV Genotyping Test, June 20, 2013
http://www.abbott.com/press-release/abbott-announces-new-test-to-help-doctors-determine-personalized-treatment-path-for-patients-with-h.htm

Clearance for New Molecular Amplification Test, June 10, 2013
http://investor.meridianbioscience.com/phoenix.zhtml?c=117257&p=irol-newsArticle&ID=1828457&highlight

Responding to H7N9 Threat, FDA Issues Emergency Use Authorization for CDC RT-PCR Diagnostic, April 26, 2013
http://www.genengnews.com/gen-news-highlights/responding-to-h7n9-threat-fda-issues-emergency-use-authorization-for-cdc-rt-pcr-diagnostic/81248283

Luminex Receives FDA Nod for Gastrointestinal Pathogen Panel, April 15, 2013
http://phx.corporate-ir.net/phoenix.zhtml?c=79403&p=irol-newsArticle&ID=1806620&highlight=

Quidel and Life Tech Receive Simultaneous Clearances fir C. difficile assay, March 18, 2013
http://phx.corporate-ir.net/phoenix.zhtml?c=94060&p=irol-newsArticle&ID=1797134&highlight=

Meridian’s Group A and B Streptococcus Tests Rated Moderate Complexity, March 18, 2013
http://investor.meridianbioscience.com/phoenix.zhtml?c=117257&p=irol-newsArticle&ID=1797403&highlight

Quidel Receives FDA Clearance for RSV + hMPV Test, March 12, 2103
http://phx.corporate-ir.net/phoenix.zhtml?c=94060&p=irol-newsArticle&ID=1794980

Roche Receives FDA Approval for HCV Test, March 6, 2013
http://www.roche.com/media/media_releases/med-cor-2013-03-06.htm

U.S. ARKRAY, Inc. Announces FDA Clearance of the Fully Automated Integrated Urine Analyzer AUTION HYBRID™ AU-4050, February 28, 2013
http://www.arkraylab.com/news/2-28-13_AU-4050.html

BioFire Receives FDA Clearance Improving Sensitivity and Reactivity of Adenovirus, February 20, 2013
http://www.biofiredx.com/pdfs/mediakit/PRESS%20RELEASE%20-%20BioFireRP1.7_FDAClearance-0043.pdf

Cepheid’s Xpert CT/NG Test Rated Moderate Complexity, January 15, 2013
http://ir.cepheid.com/releasedetail.cfm?releaseid=733538

FDA Clears Hologic Trichomonas vaginalis Assay, January 14, 2013
http://investors.hologic.com/2013-01-14-Hologic-Announces-FDA-Clearance-of-APTIMA-Trichomonas-for-Use-on-PANTHER-System

Nanosphere Receives Clearance for C. difficile Test, December 10, 2012 
http://www.nanosphere.us/investors/press-releases

FDA Approves Roche’s HPV Test for Identifying Women at Highest Risk for Cervical Cancer, April 20, 2011
http://www.roche.com/media/media_releases/med-cor-2011-04-20.htm


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