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molecular test
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UFDA Now Can Design for The Detection of Toxigenic C Difficile Bacterial Dna.
Dec 19, 2012The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...
Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology
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The European Union Has Granted CE Mark to Abacus Diagnostica's Molecular Diagnostic Assay
Dec 18, 2012The European Union has granted CE mark to Abacus Diagnostica's molecular diagnostic assay, designed for detecting toxin-producing Clostridium difficile. The GenomEra C. difficile assay, which is designed for use with the company's ...
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IntelligentMDx Received CE Mark Approval for Its Automated Molecular HSV-1/2 Test
Dec 7, 2012IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system. The HSV-1/2 for Abbott m2000 assay detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and ...
Tags: IntelligentMDx, HSV-1/2 test, Abbott m2000 system, HSV
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Quest Diagnostics Has Received FDA 510(K) Clearance
Dec 5, 2012Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler. The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is ...
Tags: Quest Diagnostics, 3M integrated cycler, Simplexa tests
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FDA Granted Approval for Great Basin's First Molecular Diagnostic Test for C. Diff
Nov 30, 2012The 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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Life Technologies Has Developed a New Molecular Test to Detect E. Coli in Beef
Jul 24, 2012US-based Life Technologies has developed a new molecular test for the detection of multiple strains of E.coli in ground beef. According to the company,the new test simultaneously detects E.coli O157:H7 and six non-O157 E.coli ...
Tags: molecular test, E.coli, ground beef, food safety, animal health
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