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December 30, 2013
16:06 EDTQDELQuidel receives FDA clearance for sale of AmpliVue Group B Strep Assay
Quidel announced that it has received 510(k) clearance from the FDA for the sale of its AmpliVue Group B Strep Assay. AmpliVue is Quidel's non-instrumented molecular diagnostic test that employs a novel amplification technology with an easy-to-use, hand-held device. The AmpliVue Group B Strep Assay combines isothermal Helicase Dependent Amplification, or HDA, with Quidel's well-established expertise in lateral flow technology to detect Group B Streptococcus, or GBS, from enriched broth cultures of specimens from antepartum women.
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