CE IVD articles & resources on Made-in-China.com

IVD-MS Analyzer in Europe Is Launched by Ab Sciex

Dec 2, 2013

AB SCIEX, a developer of mass spectrometry products, has announced the launch of its AB SCIEX IVD-MS analyzer CE marked for general in vitro diagnostic use in Europe. The release of this mass spectrometry-based analyzer is in response to ...

Tags: mass spectrometry products, Medicine

Pathogenica Received The CE Mark for HAI BioDetection Kit

Aug 16, 2013

Pathogenica has received the CE mark for its HAI BioDetection kit that runs on the Ion PGM benchtop sequencer. HAI BioDetection CE-IVD kit is a qualitative in vitro test designed for the rapid identification of bacterial organisms and ...

Tags: Pathogenica, CE Mark

BioFire Diagnostics Begun Clinical and Analytical Studies to Evaluate GI Panel

Aug 2, 2013

US-based BioFire Diagnostics has begun clinical and analytical studies to evaluate its FilmArray Gastrointestinal (GI) Panel. This clinical study is being conducted at several hospital-based clinical laboratories in the US and is funded ...

Tags: Biofire Diagnostics, Gastrointestinal Panel

Mobidiag Will Offer Integrated, High-Multiplex Diagnostic Tests for Infectious Diseases

Apr 18, 2013

Mobidiag, Genewave and Amplidiag have signed a definitive agreement to combine the three companies to set up a new company, which will offer integrated, high-multiplex diagnostic tests for infectious diseases. Headquartered in Helsinki, ...

Tags: Mobidiag, Genewave, Infectious Diseases

ISO Issues Certification for US Facilities to Thermo Fisher Scientific

Apr 3, 2013

US-based Thermo Fisher Scientific has announced that its US-based facilities have received ISO 13485 certification. The facilities in Franklin, Massachusetts and San Jose, California are the company's liquid chromatography and mass ...

Tags: Thermo Fisher, ISO Certification

CE-Ivd Registration Is Won by Epistem Genedrive Tb Test

Dec 18, 2012

The biotechnology and personalized medicine company, Epistem, has gained CE mark for its in vitro diagnostic medical device (CE-IVD), Genedrive Tuberculosis (TB) test. Epistem said the registration enables to place its TB test and ...

Tags: Epistem, CE mark, CE-IVD, diagnostic medical device, TB test

ABL Has Received CE Mark Approval

Dec 7, 2012

Advanced Biological Laboratories (ABL) has received CE mark approval for its DeepChek and ViroScore Suite clinical genotyping solutions. The approval is based on several evaluations of the company's next generation sequencing (NGS) ...

Tags: Advanced Biological, ABL, CE mark approval, evaluations

Idaho Technology Initiated Clinical Trial of Filmarray Blood Culture Identification Panel

Dec 7, 2012

Idaho Technology, a provider of instruments for pathogen identification and DNA analysis, has initiated clinical trial of its FilmArray blood culture identification (BCID) panel. The FilmArray BCID panel, which will run on the company's ...

Tags: Idaho, BCID panel, pathogen detection system

Abbott Expands CE-IVD Product Labeling for Its Vysis Alk Break Apart Fish Probe Kit

Dec 4, 2012

Abbott will expand the current CE-IVD product labeling for its Vysis ALK Break Apart FISH Probe Kit to allow the test to be marketed in the European Union as a companion diagnostic. The test uses Abbott's proprietary fluorescence in situ ...

Tags: Abbott, anaplastic lymphoma kinase, ALK, FISH technology

FDA Granted Approval for Great Basin's First Molecular Diagnostic Test for C. Diff

Nov 30, 2012

The FDA has granted approval for Great Basin's first molecular diagnostic test for Clostridium difficile (C. diff). The integrated cartridge system comprises necessary reagents to perform the assay and predict the presence of ...

Tags: molecular diagnostic test, clinical product, clinical research

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