FDA Product Code PSZ: Devices Detecting Influenza A, B, And C Virus Antigens
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.
Leading manufacturers include SEKISUI Diagnostics, LLC, Bd and Roche Diagnostics Corp..
72
Total
72
Cleared
107d
Avg days
1998
Since
Growing category -
3 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
224d
recently vs 101d historically
FDA 510(k) Cleared Devices Detecting Influenza A, B, And C Virus Antigens Devices (Product Code PSZ)
72 devices
Cleared
Jan 15, 2026
Nano-Check Influenza A+B Test
Nano-Ditech Corporation
Microbiology
177d
Cleared
Jul 03, 2025
Innovita Flu A/B Antigen Rapid Test
Innovita (Tangshan) Biological Technology Co., Ltd.
Microbiology
141d
Cleared
Apr 18, 2025
Acucy® Influenza A&B Test with the Acucy® 2 System
SEKISUI Diagnostics, LLC
Microbiology
354d
Cleared
Dec 05, 2023
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
Bd
Microbiology
116d
Cleared
Jan 27, 2023
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
Bd
Microbiology
120d
Cleared
Apr 03, 2020
Osom Ultra Plus Flu A&B Test Kit
SEKISUI Diagnostics, LLC
Microbiology
190d
Cleared
Feb 18, 2020
CareStart Flu A&B Plus
Access Bio, Inc.
Microbiology
256d
Cleared
Dec 17, 2018
Acucy Influenza A&B Test with the Acucy System
SEKISUI Diagnostics, LLC
Microbiology
144d
Cleared
Sep 18, 2018
BioSign Flu A+B
Princeton BioMeditech Corp.
Microbiology
40d
Cleared
Aug 08, 2018
Alere BinaxNOW Influenza A & B Card 2, Alere Reader
Alere Scarborough, Inc.
Microbiology
28d
Cleared
Mar 20, 2018
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
Bd
Microbiology
28d
Cleared
Feb 13, 2018
QuickVue Influenza A+B
Quidel Corporation
Microbiology
12d
Cleared
Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
Roche Diagnostics Corp.
Microbiology
184d
Cleared
Jun 28, 2000
BD DIRECTIGEN FLU A+B
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology
58d
Cleared
Dec 20, 1999
ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
Roche Diagnostics Corp.
Microbiology
101d
About Product Code PSZ - Regulatory Context
510(k) Submission Activity
72 total 510(k) submissions under product code PSZ since 1998, with 72 receiving FDA clearance (average review time: 107 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PSZ Product Code
Recent submissions under PSZ have taken an average of 224 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.
PSZ devices are reviewed by the Microbiology panel. Browse all Microbiology devices →