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BD Max enteric panel gets FDA clearance

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Jan. 11, 2019—BD announced FDA 510(k) clearance of its BD Max enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. The panel is designed for targeted detection of the viral cause of infectious diarrhea symptoms and can detect norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.

“We continue to expand our menu of unique, clinically relevant, molecular diagnostics panels to aid in diagnosis of a range of infectious diseases,” Nikos Pavlidis, vice president and general manager of molecular diagnostics and women’s health for BD, said in a press release. “With this launch, BD’s suite of assays for diagnosing gastrointestinal conditions will provide clinicians with greater flexibility for more efficient and cost-effective patient management. We also offer panels for diagnosis of hospital acquired infections including C. diff and MRSA as well as vaginal infections, common sexually transmitted infections, and group B streptococcal disease.”

The panel runs on the BD Max molecular system and can return results in less than 3.5 hours.

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