Cleared Traditional

BD Veritor? System for Rapid Detection of Flu A+B CLIA Waived Kit

K232434 · Bd · Microbiology

Dec 2023

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K232434 is an FDA 510(k) clearance for the BD Veritor? System for Rapid Detection of Flu A+B CLIA Waived Kit, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Bd (Sparks, US). The FDA issued a Cleared decision on December 5, 2023, 116 days after receiving the submission on August 11, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K232434 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 11, 2023
Decision Date	December 05, 2023
Days to Decision	116 days
Submission Type	Traditional
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.