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Tag Archives: BD Diagnostics—

Wireless POC diagnostic device, 1/17

January 2017—Becton Dickinson launched its next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus, and group A strep, with new traceability and secure patient health record documentation features and functionality.

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BD’s ‘next-gen’ blood collection tube cleared

Oct. 6, 2016—Becton, Dickinson has received Food and Drug Administration 510(k) clearance for the BD Vacutainer Barricor plasma blood collection tube. The company said the “next-generation” blood collection and separation technology is designed to improve sample quality, help clinicians receive test results faster, and ultimately improve patient care and clinical efficiency. BD Barricor is a single-use, plastic, evacuated tube used ...

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BD offers POC combo test for flu, RSV, strep

Sept. 30, 2016—Becton, Dickinson has launched a wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus, and group A strep, with new traceability and secure patient health-record documentation features and functionality. The wireless BD Veritor Plus System aims to provide health professionals and laboratorians in physician offices, clinics, hospitals, and integrated delivery networks with objective, ...

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BD submits PMA for first-line HPV test

Sept. 21, 2016—Becton, Dickinson has submitted a premarket approval application to the Food and Drug Administration for the Onclarity HPV Assay, its human papillomavirus test. The BD Onclarity HPV Assay PMA is supported by data collected during a two-year, prospective, multicenter clinical trial with more than 33,000 women enrolled. The submission seeks approval for use of the BD Onclarity HPV ...

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BD’s three-in-one STI test cleared

Sept. 19, 2016—Becton, Dickinson has obtained Food and Drug Administration clearance for the BD Max CT/GC/TV assay, which provides health professionals the ability to detect for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC) and Trichomonas vaginalis (TV) from a single specimen in one test. Specimen collection options are flexible, allowing for male or female urines, self-collected vaginal swabs and clinician-collected endocervical ...

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Malaria detection device, 6/16

June 2016—Becton Dickinson will collaborate with Sight Diagnostics to introduce the SightDX Parasight Malaria Detection Platform in India. BD will market the platform, the company’s first malaria diagnostics offering, in the Indian diagnostics market.

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CE for BD blood separation technology

March 9, 2016—Becton, Dickinson has obtained the CE mark in for a next-generation blood separation technology that is designed to enhance sample quality, improve laboratory efficiency, and reduce laboratory turnaround time. The BD Vacutainer Barricor tube is a single-use, plastic evacuated tube used to collect, separate, transport, and process venous blood specimens to obtain high-quality plasma for in vitro diagnostic ...

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Automated cervical cancer screening system cleared

March 7, 2016—Becton, Dickinson has received Food and Drug Administration approval for its BD Totalys MultiProcessor and BD Totalys SlidePrep instruments. Together with the BD FocalPoint SlideProfiler, these products comprise the full BD Totalys System, which further automates slide preparation, imaging, and review for use in cervical cancer screening, as well as providing ancillary testing aliquot capability. The BD DataLink ...

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Chip prep module, 11/15

November 2015—Agena Bioscience introduced the Chip prep moduleto automate sample handling after polymerase chain reaction for the MassArray 96-well System. This enables laboratories to operate the MassArray System largely unattended for high-throughput, multiplex genetic analysis.

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New molecular test for Trichomonas vaginalis, 10/13

BD Diagnostics announced FDA clearance of its BD ProbeTec Trichomonas vaginalis Qx amplified DNA assay for the direct qualitative detection of T. vaginalis DNA in endocervical samples, vaginal samples, and neat urine specimens. This assay, developed to aid in the diagnosis of trichomoniasis, has been CE marked to the in vitro diagnostic directive.

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