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Quidel Corp receives FDA clearance for its hand-held molecular diagnostic test

Monday, 30 Dec 2013 04:05pm EST 

Quidel Corp:Says it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay.Says AmpliVue is Quidel's non-instrumented molecular diagnostic test that employs a novel amplification technology with an easy-to-use, hand-held device.Says AmpliVue Group B Strep Assay combines isothermal Helicase Dependent Amplification with Quidel's well-established expertise in lateral flow technology to detect Group B Streptococcus from enriched broth cultures of specimens from antepartum women. 

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