510(k) for AMDL:
This article was originally published in Clinica
The FDA has cleared AMDL's PyloriProbe diagnostic test for marketing in the US. The non-invasive direct enzyme immunoassay is designed to detect the presence of antibodies to the H pylori bacteria in from blood samples. The H pylori bacteria is known to cause gastric and duodenal ulcers which could lead to stomach cancer if left untreated.
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