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This article was originally published in Clinica
Saliva Diagnostic Systems has submitted an application for 510(k) clearance of its Stat-Simple rapid whole blood test for the ulcer causing bacterium H pylori. Data from trials of the test showed that it has a sensitivity of 91.5% and a specificity of 99.6%. It is the company's first submission for a diagnostic test based on its SDS platform technology.
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