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Medical Devices / Submissions and Approvals

FDA Clears Becton Dickinson’s Enteric Viral Panel

Dec. 28, 2018

The FDA granted Becton Dickinson 510(k) clearance for its molecular diagnostic test, the BD MAX enteric viral panel.

The test detects enteric viral pathogens that cause viral gastroenteritis and can distinguish between them.

The BD MAX can perform targeted detection for norovirus, rotavirus, adenovirus, human astrovirus and sapovirus.

The enteric panels run on the BD MAX molecular system and can provide results in less than 3.5 hours.

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