BD Veritor™ System Flu A+B Assay

Devices Detecting Influenza A, B, And C Virus Antigens

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Veritor™ System Flu A+b Assay.

Pre-market Notification Details

• Device ID: K133138
• 510k Number: K133138
• Device Name: BD Veritor™ System Flu A+B Assay
• Classification: Devices Detecting Influenza A, B, And C Virus Antigens
• Applicant: BECTON DICKINSON & CO. 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92121
• Contact: Gregory P Payne
• Correspondent: Gregory P Payne; BECTON DICKINSON & CO. 10865 ROAD TO THE CURE, SUITE 200 San Diego, CA 92121
• Product Code: PSZ
• CFR Regulation Number: 866.3328 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-17
• Decision Date: 2013-11-13
• Summary: summary