Hologic Says Gastroenteritis Tests Get US FDA Clearance, CE Mark
MT Newswires Live
Oct 02, 2025
Hologic (HOLX) said Thursday that its automated molecular tests designed for detecting the most common causes of infectious gastroenteritis have received 510(k) clearance from the US Food and Drug Administration.
The Panther Fusion Gastrointestinal Bacterial and Expanded Bacterial Assays have also received CE marking in the European Union in accordance with In Vitro Diagnostic Regulation, the company said.
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