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FDA Clears Techlab's H. Pylori Tests

NEW YORK (360Dx) – Gastrointestinal diagnostics firm Techlab said today that the US Food and Drug Administration has provided 510(k) clearance for two of the company's tests for aid in diagnosing H. pylori infection.

One test, the H. Pylori Quick Chek, is a rapid diagnostic test that detects H. pylori in 30 minutes. The other test, the H. Pylori Chek, is a 96-well plate format for laboratories that tests large numbers of specimens. Results can be achieved with or without automation in one hour, Techlab said, adding both tests offer flexible transport conditions, including room temperature storage of specimens and the use of C&S and Cary Blair transport media to simplify sample collection for patients and physicians.

Based in Blacksburg, Virginia, Techlab offers diagnostic tests for enteric diseases caused by Clostridium difficile, food-borne pathogens, and protozoan parasites. In January, the FDA cleared two of the company's tests intended to aid in diagnosing campylobacteriosis.