Diagnostic Test for H pylori

August 1, 1996

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.

TUSTIN, Ca--AMDL, Inc. has filed a 510(k) Premarket Notificationwith the FDA for PyloriProbe, its diagnostic test for the detectionof Heli-cobacter pylori. This bacterium is associated withchronic gastritis and gastric and duodenal ulcers, and has beenclassified by WHO as a class I carcinogen that increases the riskof developing stomach cancer. Pylori-Probe is a direct enzymeimmunoassay (EIA) that detects the presence of H pyloriantibodies in serum samples.