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FDA Clearance for Au...

CLIA Waiver for Digital Result Group A Strep Test


BD Diagnostics has received 510(k) clearance and CLIA Waiver from the FDA for the BD Veritor™ System for Rapid Detection of Group A Strep. This is the first commercially available rapid Group A Strep test system that incorporates a digital result to receive CLIA Waiver. The new assay is cleared for use in hospitals, outpatient clinics and other patient-care settings.

When used in conjunction with the BD Veritor System Reader, the Group A Strep test utilizes Advanced Nano-particle and Adaptive Read technologies to obtain an accurate result while providing objective results on a hand held reader with an easy-to-read digital display. This digital immunoassay (DIA) for Rapid Detection of Group A Strep offers healthcare professionals a new option for Group A Strep testing versus current visual read CLIA-waived assays.

The BD Veritor System for Rapid Detection of Group A Strep joins the previously FDA-cleared and CLIA-waived BD Veritor™ System for Rapid Detection of Flu A+B and FDA-cleared BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus. These assays work in conjunction with the BD Veritor System Reader. BD plans to continue to launch additional assays on this new platform.


    

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Date Published: 10th March 2014

Source article link: BD diagnostics


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