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FDA Updates

BioFire Defense receives Emergency Use Authorization from FDA dor FilmArray Ebola Test, October 27, 2014
http://www.biofiredx.com/media/Final-Ebola-Press-Release.pdf

First ZnT8 Autoantibody Test for the Diagnosis of Type 1 Diabetes Approved by FDA, August 20, 2014
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410830.htm

FDA Approves Quidel for Handheld Group A Strep Test, July 28, 2014
http://ir.quidel.com/phoenix.zhtml?c=94060&p=irol-newsArticle&ID=1951921

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


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