http://www.microdiscovery.de/ MicroDiscovery news and eventsen http://www.microdiscovery.de/fileadmin/default/templates/images/favicon.ico http://www.microdiscovery.de/ 3232MicroDiscovery news and eventsTYPO3 - get.content.righthttp://blogs.law.harvard.edu/tech/rssTue, 31 Jan 2012 11:48:00 +0100 http://www.microdiscovery.de/news-events/article/hands-on-workshop-spotting-protein-arrays.html The MPC will give Hands-On protein microarray workshops:"Spotting Protein Arrays" and...Events Tue, 31 Jan 2012 11:48:00 +0100 http://www.microdiscovery.de/news-events/article/cto-dr-dieter-beule-at-the-potsdam-days-on-bioanalysis-zmdb.html MicroDiscoverys CTO Dr.Dieter Beule gave a lecture on "New Technologies for IvD" at the...Lecture Wed, 16 Nov 2011 09:35:00 +0100 http://www.microdiscovery.de/news-events/article/a-successful-cooperationmicrodiscovery-and-bayer-schering-pharma.html MicroDiscovery and Bayer Schering Pharma prolong their successful cooperation.News Sat, 10 Sep 2011 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/multiplex-assays-workshop.html MicroDiscovery will participate in the workshop 'MULTIPLEX ASSAYS: "Science Facts &...Events Fri, 02 Sep 2011 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/visit-us-at-biotechnica.html MicroDiscovery will be attending Biotechnica 2011, October 11-13, Europe's leading biotech trade... Biotechnica 2011, October 11-13,
Europe's leading biotech trade fair. You will find us in hall 9, booth
C26. We would be pleased to see you in Hannover!  
]]> Events Thu, 01 Sep 2011 13:57:00 +0200 http://www.microdiscovery.de/news-events/article/genespotter-for-free.html Get your free full featured GeneSpotter microarray image analysis software for 30 days. Discover... Discover the power of automatic grid finding and batch processing. Enjoy the easy to use user interface. Learn how to define your personalised analysis reports using the Excel(TM) interface. Download the new GeneSpotter 4.0 software for MS Windows7 from our FTP site.
Please contact our support team for your personal 30 day test licence. Email:support(at)microdiscovery.de ]]> Events Wed, 18 May 2011 11:33:00 +0200 http://www.microdiscovery.de/news-events/article/biotechnika.html New version of the analytical software GeneSpotter Press release (PDF)  ]]> Press release Mon, 04 Oct 2010 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/microdiscovery-and-bayer-schering-pharma-prolong-their-succesful-cooperation.html MicroDiscovery and Bayer Schering Pharma prolong their successful cooperation Press release Mon, 04 Oct 2010 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/dr-dieter-beule-on-medicinal-software-and-life-cycle-management.html in Berlin on Sep 29 2010 Lecture Sat, 25 Sep 2010 22:30:00 +0200 http://www.microdiscovery.de/news-events/article/medical-technology-and-in-virto-diagnostics.html on July 09 2010 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori. CDRH is requesting feedback on the draft guidance; those wishing to comment should do so within 90 days. (Submit comments electronically here. Identify all comments with the docket number 1712.)
The document is a revision of the 16-year-old "Guidance for Industry and FDA Staff: Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori." It is updated to include alternate test methods (non-antibody-based detection) that are currently being used to detect H. pylori. These methods include the stool antigen test, the urease test, blood and urine antibody tests, and the carbon-urea breath test. They are all discussed in this new document.
Section V of this draft guidance is titled "Establishing Performance Characteristics" and includes subsections on general recommendations, controls, analytical studies, clinical performance studies, and CLIA waiver. 
For recent IVD Technology stories on H. pylori, click here.]]> Press release Sat, 25 Sep 2010 15:25:00 +0200 http://www.microdiscovery.de/ MicroDiscovery news and events en http://www.microdiscovery.de/fileadmin/default/templates/images/favicon.ico http://www.microdiscovery.de/ 32 32 MicroDiscovery news and events TYPO3 - get.content.right http://blogs.law.harvard.edu/tech/rss Tue, 31 Jan 2012 11:48:00 +0100 http://www.microdiscovery.de/news-events/article/hands-on-workshop-spotting-protein-arrays.html The MPC will give Hands-On protein microarray workshops: "Spotting Protein Arrays" and... Events Tue, 31 Jan 2012 11:48:00 +0100 http://www.microdiscovery.de/news-events/article/cto-dr-dieter-beule-at-the-potsdam-days-on-bioanalysis-zmdb.html MicroDiscoverys CTO Dr.Dieter Beule gave a lecture on "New Technologies for IvD" at the... Lecture Wed, 16 Nov 2011 09:35:00 +0100 http://www.microdiscovery.de/news-events/article/a-successful-cooperationmicrodiscovery-and-bayer-schering-pharma.html MicroDiscovery and Bayer Schering Pharma prolong their successful cooperation. News Sat, 10 Sep 2011 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/multiplex-assays-workshop.html MicroDiscovery will participate in the workshop 'MULTIPLEX ASSAYS: "Science Facts &... Events Fri, 02 Sep 2011 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/visit-us-at-biotechnica.html MicroDiscovery will be attending Biotechnica 2011, October 11-13, Europe's leading biotech trade... Biotechnica 2011, October 11-13,
Europe's leading biotech trade fair. You will find us in hall 9, booth
C26. We would be pleased to see you in Hannover!  
]]> Events Thu, 01 Sep 2011 13:57:00 +0200 http://www.microdiscovery.de/news-events/article/genespotter-for-free.html Get your free full featured GeneSpotter microarray image analysis software for 30 days. Discover... Discover the power of automatic grid finding and batch processing. Enjoy the easy to use user interface. Learn how to define your personalised analysis reports using the Excel(TM) interface. Download the new GeneSpotter 4.0 software for MS Windows7 from our FTP site.
Please contact our support team for your personal 30 day test licence. Email:support(at)microdiscovery.de ]]> Events Wed, 18 May 2011 11:33:00 +0200 http://www.microdiscovery.de/news-events/article/biotechnika.html New version of the analytical software GeneSpotter Press release (PDF)  ]]> Press release Mon, 04 Oct 2010 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/microdiscovery-and-bayer-schering-pharma-prolong-their-succesful-cooperation.html MicroDiscovery and Bayer Schering Pharma prolong their successful cooperation Press release Mon, 04 Oct 2010 00:00:00 +0200 http://www.microdiscovery.de/news-events/article/dr-dieter-beule-on-medicinal-software-and-life-cycle-management.html in Berlin on Sep 29 2010 Lecture Sat, 25 Sep 2010 22:30:00 +0200 http://www.microdiscovery.de/news-events/article/medical-technology-and-in-virto-diagnostics.html on July 09 2010 Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori. CDRH is requesting feedback on the draft guidance; those wishing to comment should do so within 90 days. (Submit comments electronically here. Identify all comments with the docket number 1712.)
The document is a revision of the 16-year-old "Guidance for Industry and FDA Staff: Review Criteria for Assessment of Laboratory Tests for the Detection of Antibodies to Helicobacter pylori." It is updated to include alternate test methods (non-antibody-based detection) that are currently being used to detect H. pylori. These methods include the stool antigen test, the urease test, blood and urine antibody tests, and the carbon-urea breath test. They are all discussed in this new document.
Section V of this draft guidance is titled "Establishing Performance Characteristics" and includes subsections on general recommendations, controls, analytical studies, clinical performance studies, and CLIA waiver. 
For recent IVD Technology stories on H. pylori, click here.]]> Press release Sat, 25 Sep 2010 15:25:00 +0200