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Articles tagged with: BD

CPO assay gets CE mark, 3/18

March 2018—Becton Dickinson and Check-Points obtained the CE mark for a next-generation molecular screening test for antibiotic-resistant carbapenemase-producing organisms on the BD Max System.

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 …

BD, Check-Points get CE mark for CPO assay

Jan. 26, 2018—Becton Dickinson and Check-Points obtained the CE mark for a next-generation molecular screening test for antibiotic-resistant …

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 …

FDA 510(k) clearance for BD FACSVia, 7/17

July 2017—Becton Dickinson received 510(k) clearance from the FDA for its BD FACSVia, a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.

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.

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 …

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