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In Brief: Meretek

This article was originally published in The Gray Sheet

Executive Summary

Meretek: Begins shipping UBT H. pylori breath test in the U.S. market. The non-invasive test, which is being promoted as a lower-cost alternative to endoscopy with stomach biopsy, uses non-radioactive technology to diagnose active H. pylori. The UBT test gained FDA marketing clearance via a joint 510(k)/new drug application in September ("The Gray Sheet" Sept. 23, I&W-7). FDA required the NDA submission because Pranaetin, a non-radioactive diagnostic drug, is consumed by patients taking the test...
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