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# Meridian Bio’s H. pylori Test Cleared
- URL: https://www.fdaweb.com/meridian-bios-h-pylori-test-cleared/
- Published: 2023-07-25T12:00:00.000Z
- Updated: 2026-09-14T18:46:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154949

FDA has cleared a Meridian Bioscience 510(k) for its Premier HpSA FLEX for diagnosing *Helicobacter pylori*. The enzyme immunoassay is used to qualitatively detect *H. pylori-*specific antigens in fresh, frozen, or preserved human fecal specimens, according to the company. *H. pylori* infection is linked to several significant upper gastrointestinal conditions, including chronic gastritis, peptic ulcer disease, and gastric cancer. Once diagnosed, the infection can be easily treated with antibiotics, it says.