FDA Grants Clearance for Group A Strep Test

BD Diagnostics announced that the FDA has granted 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) Waiver for the BD Veritor System for Rapid Detection of Group A Strep. This is the first test Group A Strep test system with digital results that has received the CLIA Waiver.

The Group A Strep test incorporates Advanced Nano-particle and Adaptive Read technologies to obtain an accurate result while showing results on a hand held reader with an easy-to-read digital display. This digital immunoassay (DIA) for Rapid Detection of Group A Strep is a new option for Group A testing compared to the current visual read CLIA-waived assays.

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Test results are delivered in about 8 minutes from specimen processing to results. Accurate determination of the etiology can aid healthcare providers choose more appropriate antibiotic treatments.

The BD Veritor System for Rapid Detection of Group A Strep is cleared for use in hospitals, outpatient clinics, and other patient-care settings in conjunction with the BD Veritor System Reader.

For more information call (800) 638-8663 or visit BD.com