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Product Withdrawn at FDA Request

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AMDL Inc., a biomedical company, said the Food and Drug Administration asked the firm to withdraw its application to sell a test for a stomach-irritating bacteria until it provides additional clinical data.

AMDL’s test, PyloriProbe, is designed to detect the presence of H. pylori, which is associated with ulcers.

AMDL said additional studies of PyloriProbe are in progress and that it plans to resubmit its application with the FDA. PyloriProbe is only available for distribution outside the U.S.

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