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Tag Archives: BD—

BD Max enteric panel gets FDA clearance

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 ...

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BD HPV assay gets premarket approval

March 8, 2018—Becton Dickinson received premarket approval from the FDA for the BD Onclarity HPV assay. The test detects 14 types of high-risk human papillomavirus from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers and ...

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BD Kiestra urine culture app

July 24, 2017—Becton Dickinson announced new technology that can automatically report and release negative urine cultures. The BD Kiestra urine culture app, together with BD BBL plated media, uses digital imaging and software algorithms to determine the amount of growth on a urine culture plate from clean caught and catheterized samples. Using the BD Kiestra ReadA compact’s incubation and imaging ...

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