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Tag Archives: BD—

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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BD Veritor meets new FDA flu requirements, 5/17

May 2017—Becton Dickinson announced that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements in which antigen-based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens have been reclassified from class I de­vices to class II devices subject to special controls.

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BD Veritor meets new FDA flu requirements

March 17, 2017—Becton Dickinson announced that its BD Veritor System Flu A+B, a digital immunoassay for the rapid detection of influenza, meets the new FDA performance requirements in which antigen-based rapid influenza virus antigen detection systems (RIDTs) intended to detect influenza virus directly from clinical specimens have been reclassified from class I devices to class II devices subject to special ...

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