Cleared Special

BD Veritor? System Flu A+B Assay

K133138 · Becton, Dickinson & CO · Microbiology

Nov 2013

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K133138 is an FDA 510(k) clearance for the BD Veritor? System Flu A+B Assay, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Becton, Dickinson & CO (San Diego, US). The FDA issued a Cleared decision on November 13, 2013, 27 days after receiving the submission on October 17, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K133138 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2013
Decision Date	November 13, 2013
Days to Decision	27 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3328
Definition	An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.