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Diagnostic Test for H pylori

Diagnostic Test for H pylori

TUSTIN, Ca--AMDL, Inc. has filed a 510(k) Premarket Notification with the FDA for PyloriProbe, its diagnostic test for the detection of Heli-cobacter pylori. This bacterium is associated with chronic gastritis and gastric and duodenal ulcers, and has been classified by WHO as a class I carcinogen that increases the risk of developing stomach cancer. Pylori-Probe is a direct enzyme immunoassay (EIA) that detects the presence of H pylori antibodies in serum samples.

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