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FDA Clears TechLab’s Gastrointestinal Diagnostic Tests

August 22, 2018

The FDA granted 510(k) clearance for two TechLab gastrointestinal disease diagnostic tests, the H. pylori Chek and QuikChek tests.

Both tests are designed to help in the diagnosis of Helicobacter pylori infection, a bacterial infection linked to peptic ulcers.

The QuikChek test can diagnose infection in 30 minutes, while the Chek test is a 96-well plate format diagnostic used in laboratories for diagnosing large numbers of specimens in an hour.

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