Hologic Says Gastroenteritis Tests Get US FDA Clearance, CE Mark

MT Newswires Live
2025/10/02

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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