Tag: FDA


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Beckman Coulter Receives FDA Clearance on Vitamin D Total Assay for Use on Access 2 and UniCel DxI Immunoassay Systems8 Jan 2015Read
Revolutionize Routine Medical Testing with Latest ‘Super-Control’ from Randox7 Jan 2015Read
diaDexus, Inc. Receives FDA Clearance for PLAC Activity Test to Assess Coronary Heart Disease Risk31 Dec 2014Read
U.S. Food and Drug Administration Grants CLIA Waiver for Alere Determine™ HIV-1/2 Ag/Ab Combo Test29 Dec 2014Read
Quidel Receives FDA Clearance for its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Bordetella Pertussis23 Dec 2014Read
FDA Clears the Focus Diagnostics Simplexa™ Flu A/B & RSV Direct Test to Include Eight Circulating Influenza Viruses18 Dec 2014Read
FDA: Study Demonstrates Potential for Faster Drug Development18 Dec 2014Read
MP Biomedicals Receives First Ever FDA Approval for HTLV Confirmatory Assay15 Dec 2014Read
Vela Diagnostics Announces the Listing of their Next-Generation Sequencing System with the U.S. FDA as a Class II Medical Device20 Nov 2014Read
8 Recent FDA Medical Device Announcements27 Oct 2014Read

  Application Articles

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Improving Data Reliability and Laboratory Efficiency Testing of Fluoroquinolones in Fatty and Non-Fatty Fish Samples with One Method using Automated Solid Phase Extraction and New Consumable Technologies11 Feb 2015Read
Unraveling the Exclusivity Determination for Prodrugs12 May 2014Read
A Model for Pharmaceutical Supply Chain Quality Agreements7 Mar 2014Read
Laser Diffraction and Automated Imaging: Complementary Techniques for Nasal Spray3 Mar 2014Read
Vero Cell-based Vaccine Production: Rabies and Influenza Cell lines, Media and Bioreactor Options26 Feb 2014Read
Rapid, Reliable Metabolite Ratio Evaluation for MIST Assessments in Drug Discovery and Preclinical Studies12 Dec 2012Read
An In Silico Test Battery For Rapid Evaluation of Genotoxic and Carcinogenic Potential of Chemicals9 Apr 2012Read
Replacing Multiple 50-Minute GC and GC-MS/SIM Analyses with One 15-Minute Full-Scan GC-MS Analysis for Nontargeted Pesticides Screening20 Mar 2012Read


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Analysis of Dietary Supplements5 Nov 2012Watch